TiLink-L Implant Caddy

GUDID 00810131880248

SURGENTEC, LLC

Orthopaedic fixation plate, bioabsorbable
Primary Device ID00810131880248
NIH Device Record Key8461e6cb-49bc-465f-a41c-a5271ff766ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiLink-L Implant Caddy
Version Model NumberSR21-7001
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 Usetrue
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
GS100810131880248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


[00810131880248]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-11
Device Publish Date2024-11-01

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