GUDID 20643169938735

ELECTRODE 8227419 5PK PRASS PRD 4CH ROHS

MEDTRONIC XOMED, INC.

Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use Electromyographic needle electrode, single-use
Primary Device ID20643169938735
NIH Device Record Key9c73ca4d-4c7a-48cc-a793-0820dbe64401
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8227419
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169938731 [Primary]
GS120643169938735 [Package]
Contains: 00643169938731
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GXZELECTRODE, NEEDLE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-03-26

Devices Manufactured by MEDTRONIC XOMED, INC.

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00763000034849 - Sheehy HA/C Polycel® T.O.P.2024-05-20 PROSTHESIS 1112363 SHEEHY TOP H/A POLYCL
00763000036591 - Big Easy® Piston2024-05-20 PROSTHESIS 1156611 PLAT/TI .5X4.5MM LFT
00763000036607 - Big Easy® Piston2024-05-20 PROSTHESIS 1156612 PLAT/TI .5X4.75MM LFT
00763000036614 - Big Easy® Piston2024-05-20 PROSTHESIS 1156613 PLAT/TI .5X5MM LEFT
00763000036621 - Big Easy® Piston2024-05-20 PROSTHESIS 1156621 PLAT/TI .5X4.5MM RT
00763000036638 - Big Easy® Piston2024-05-20 PROSTHESIS 1156622 PLAT/TI .5X4.75M RT
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