GII 212094

GUDID 10886705001910

GII Inserter

DEPUY MITEK, LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID10886705001910
NIH Device Record Key9df29bcf-476e-4233-9980-03ef4c59f886
Commercial Distribution StatusIn Commercial Distribution
Brand NameGII
Version Model Number212094
Catalog Number212094
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
GS110886705001910 [Primary]

FDA Product Code

GEFAPPLIER, STAPLE, SURGICAL,

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10886705001910]

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

On-Brand Devices [GII]

10886705003761Gll Arthroscopic Inserter
10886705001910GII Inserter
10886705000975GII Anchor Threader Tab
10886705002610Slotted Drill Guide GII / SUPER / RC / GLS
10886705001743Arthroscopic GII Drill Bit 2.4mm
10886705001576GII Drill Bit 2.4mm
20886705000941GII Anchor Threader Tab

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