Colink Standard CL

GUDID 00812444028850

Suture button loop

RIVERPOINT MEDICAL, LLC

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00812444028850
NIH Device Record Key98212ada-81cf-4d84-a7f6-a1b9a204a49a
Commercial Distribution StatusIn Commercial Distribution
Brand NameColink Standard CL
Version Model NumberTEK-OBCL-12
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
GS100812444028850 [Primary]
GS100812444028850 [Primary]
GS100812444028850 [Primary]
GS100812444028850 [Primary]

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue
MBIFastener, Fixation, Nondegradable, Soft Tissue
MBIFastener, Fixation, Nondegradable, Soft Tissue
MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

On-Brand Devices [Colink Standard CL]

00812444028577Suture Button Loop
00812444028560Suture Button Loop
00812444028553Suture Button Loop
00812444028546Suture Button Loop
00812444028539Suture Button Loop
00812444028522Suture Button Loop
00812444028515Suture Button Loop
00812444028508Suture Button Loop
00812444028416Does not contain
00812444028409Suture Button Loop
00812444028850Suture button loop

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