3910-100-015

GUDID 37613154175018

3MM GLENOID ANCHOR WITH 1 STRAND #2 FORCE FIBER

STRYKER CORPORATION

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID37613154175018
NIH Device Record Key03d9d7bd-9785-4f09-9178-7559443df3e9
Commercial Distribution StatusIn Commercial Distribution
Version Model Number3910-100-015
Catalog Number3910-100-015
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
GS107613154175017 [Primary]
GS137613154175018 [Package]
Contains: 07613154175017
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

Devices Manufactured by STRYKER CORPORATION

37613327576802 - PELLO2024-11-21 4mm Angled 15 Degree Diamond Bur
37613327576826 - PELLO2024-11-21 4mm Angled 70 Degree Diamond Bur
07613327579031 - PELLO2024-11-21 4mm Angled 15 Degree Diamond Bur
07613327579055 - PELLO2024-11-21 4mm Angled 70 Degree Diamond Bur
07613327261820 - MAC2024-10-29 SCREWDRIVER
07613327271089 - DYNATRAN2024-10-29 COMPRESSOR
07613327273885 - Aero-LL2024-10-29 INSERTER - DISTRACTOR
37613327566162 - Neptune2024-10-23 V2 SPECIMEN COLLECTION MANIFOLD KIT

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.