GUDID 00613994896704

PROBE 8225751 BALL TIP W/STIM RET 2.3MM

MEDTRONIC XOMED, INC.

Nerve-locating system, line-powered Nerve-locating system, line-powered Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system Nerve-locating system
Primary Device ID00613994896704
NIH Device Record Keyeffe9a82-c7a5-41cd-92c2-85ab4ea8a428
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8225751
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter
Length2.3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994896704 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IKNElectromyograph, diagnostic

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 Date2016-05-02

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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