TenoMend

GUDID 00813954020709

Collagen Tendon Wrap

COLLAGEN MATRIX, INC.

Multi-purpose surgical mesh, collagen, bioabsorbable
Primary Device ID00813954020709
NIH Device Record Key68bc60e7-e640-4267-9446-5aba434e405f
Commercial Distribution StatusIn Commercial Distribution
Brand NameTenoMend
Version Model NumberCTW12025
Company DUNS176262442
Company NameCOLLAGEN MATRIX, INC.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954020709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTMMesh, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-23

On-Brand Devices [TenoMend]

00813954020730Collagen Tendon Wrap
00813954020723Collagen Tendon Wrap
00813954020716Collagen Tendon Wrap
00813954020709Collagen Tendon Wrap
00813954020693Collagen Tendon Wrap
00813954020686Collagen Tendon Wrap

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