TiLink-P Instrument Removal Tool

GUDID 00850040139976

SURGENTEC, LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00850040139976
NIH Device Record Key9def9e18-bc6d-4e98-9e6e-89b502c5da1b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiLink-P Instrument Removal Tool
Version Model NumberSR16-6800
Company DUNS004095409
Company NameSURGENTEC, LLC
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850040139976 [Primary]

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


[00850040139976]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-26
Device Publish Date2024-08-16

On-Brand Devices [TiLink-P Instrument Removal Tool]

00850040139976SR16-6800
00810131880347SR16-3800

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