Burr Hole Cover

GUDID 00855547005205

The Burr Hole Cover package contains 1 Burr Hole Cover.

Neuropace, Inc.

Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover Cranial bur hole cover
Primary Device ID00855547005205
NIH Device Record Keydbf4325a-4fb3-415d-a652-ede286b8a71a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBurr Hole Cover
Version Model Number8110
Company DUNS123369238
Company NameNeuropace, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com
Phone+1(866)726-3876
Emailcustomerservice@neuropace.com

Device Dimensions

Outer Diameter14 Millimeter
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter
Device Size Text, specify0
Outer Diameter14 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment TemperatureBetween -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100855547005205 [Primary]

FDA Product Code

GXRCOVER, BURR HOLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-23

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00855547005397 - Connector Cover Kit2020-03-24 The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
00855547005298 - NeuroPace® Depth Lead Kit2020-03-23 The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw
00855547005304 - NeuroPace® Cortical Strip Lead Kit2020-03-23 The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool S

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