TiLink-L Implant 45mm x 10mm

GUDID 00810131880460

SURGENTEC, LLC

Laparoscopic access cannula anchor, single-use
Primary Device ID00810131880460
NIH Device Record Keyd35f6fd5-0d08-4347-bbd6-b5f8f7b28e2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiLink-L Implant 45mm x 10mm
Version Model NumberSI-L-45
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
GS100810131880460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


[00810131880460]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-18
Device Publish Date2025-06-10

Devices Manufactured by SURGENTEC, LLC

00810131880439 - TiLink-L Implant 30mm x 10mm2025-06-18
00810131880446 - TiLink-L Implant 35mm x 10mm2025-06-18
00810131880453 - TiLink-L Implant 40mm x 10mm2025-06-18
00810131880460 - TiLink-L Implant 45mm x 10mm2025-06-18
00810131880460 - TiLink-L Implant 45mm x 10mm2025-06-18
00810131880477 - TiLink-L Implant 50mm x 10mm2025-06-18
00810131880484 - TiLink-L Implant 55mm x 10mm2025-06-18
00810131880491 - TiLink-L Implant 60mm x 10mm2025-06-18
00810131880613 - TiLink-P Screw 12mm x 30mm2025-06-18

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