Colink Adjustable Loop

GUDID 00812444028430

Suture Button Loop

RIVERPOINT MEDICAL, LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00812444028430
NIH Device Record Key94d7fe81-89c0-4d0d-b2a8-574e70f4ceda
Commercial Distribution StatusIn Commercial Distribution
Brand NameColink Adjustable Loop
Version Model NumberTEK-OBAL-80
Company DUNS964053560
Company NameRIVERPOINT MEDICAL, 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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812444028430 [Primary]

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-03-21
Device Publish Date2018-07-05

Devices Manufactured by RIVERPOINT MEDICAL, LLC

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