212123

GUDID 10886705001934

Mini Syringe Inserter

DEPUY MITEK, LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID10886705001934
NIH Device Record Key2199da04-36b0-4202-9f36-d04700275e10
Commercial Distribution StatusIn Commercial Distribution
Version Model Number212123
Catalog Number212123
Company DUNS190572854
Company NameDEPUY MITEK, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886705001934 [Primary]

FDA Product Code

GEFAPPLIER, STAPLE, SURGICAL,

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886705001934]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-23
Device Publish Date2015-09-01

Devices Manufactured by DEPUY MITEK, LLC

20886705002174 - PANACRYL2024-06-03 Rotator Cuff EasyAnchor with PANACRYL Size 2 (5 metric) PANACRYL braided absorbable suture, 36 Inches (91 cm), double-armed with
10886705008292 - FASTIN PANACRYL2024-06-03 FASTIN RC Anchor with PANACRYL Titanium Anchor with two Number 2 PANACRYL Poly (L-Lactide/Glycolide) Braided Absorbable Sutures,
10886705009374 - VAPR2024-06-03 VAPR LD Suction Electrode 4 mm x 160 mm
10886705009381 - VAPR2024-06-03 VAPR LP Suction Electrode 4 mm x 160 mm
10886705000913 - NA2024-05-30 Rotator Cuff Anchor Threader Tab
10886705001064 - LUPINE ORTHOCORD2024-05-30 LUPINE Loop Plus Anchor w/ORTHOCORD Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD Braided Composite Sut
10886705001071 - LUPINE ORTHOCORD2024-05-30 LUPINE Loop PLUS Dual Suture (DS) Anchor w/ORTHOCORD PLA Absorbable Anchor, with two size 2 (5 metric) ORTHOCORD braided composi
10886705002412 - QUICKANCHOR PANACRYL2024-05-30 MINILOK QUICKANCHOR Plus (Number 2/0) Suture Poly (L-lactide) absorbable anchor, size 2/0 PANACRYL braided absorbable suture (3

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