3910-100-035

GUDID 37613154015307

5MM CUFF ANCHOR WITH 2 STRANDS #2 FORCE FIBER, 2 CHANNELS

STRYKER CORPORATION

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID37613154015307
NIH Device Record Key95cc6fea-e631-4551-b494-fdea830d5371
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3910-100-035
Catalog Number3910-100-035
Company DUNS187502109
Company NameSTRYKER CORPORATION
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

Customer Support Contacts

Phone+1(866)624-4422
Emailxx@xx.xx

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS107613154015306 [Primary]
GS137613154015307 [Package]
Contains: 07613154015306
Package: pack [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Number5
Public Version Date2019-03-21
Device Publish Date2015-09-04

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