FDA.reportPublic FDA data

GII

Primary DI
10886705001910
Brand
GII
Company
DEPUY MITEK, LLC
Model
212094
Catalog number
212094
Device description
GII Inserter
Published
2015-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEFAPPLIER, STAPLE, SURGICAL,

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEFApplier, Staple, Surgical,General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705001910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500191010886705001910

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
190572854
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705001804QUICKANCHOR ETHIBOND2120322120322015-09-01
10886705002535QUICKANCHOR ETHIBOND2128662128662015-09-01
10886705002542QUICKANCHOR ETHIBOND2128672128672015-09-01
10886705003747NA2145282145282015-09-01
10886705006892NA2198132198132017-03-17
10886705006908NA2198142198142017-03-17
10886705006922NA2198162198162017-03-17
10886705013098INTRAFIX2546032546032015-09-01
10886705013104NA2546042546042015-09-01
10886705013128INTRAFIX2546092546092015-09-01
10886705013531INTRAFIX2546712546712015-09-01
10886705020607FMS DUO2845802845802015-09-01
10886705020614FMS SOLO2845902845902015-09-01
10886705022397INTRAFIX2546532546532015-09-01
10886705023431HEALIX ADVANCE2223352223352015-09-01
10886705023455HEALIX ADVANCE2223332223332015-09-01
10886705023486HEALIX ADVANCE2223342223342015-09-01
10886705002399QUICKANCHOR ETHIBOND2128502128502015-09-01
10886705002405QUICKANCHOR ETHIBOND TAPERCUT2128512128512015-09-01
10886705002443MICROFIX QUICKANCHOR ETHIBOND2128552128552015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653300532HI-LINEAesculap AGGEF2020-04-23
04038653300570HI-LINEAesculap AGGEF2020-04-23
04038653300587HI-LINEAesculap AGGEF2020-04-23
00192896090675MICHEL CLIP APPLIER/REMOVER FORCEPSSONTEC INSTRUMENTS, INC.GEF2019-03-07
10886705013142INTRAFIXDEPUY MITEK, LLCGEF2017-03-17
00889024024540NAZimmer, Inc.GEF2016-07-27
10886705009930NADEPUY MITEK, LLCGEF2015-09-01
10886705010059NADEPUY MITEK, LLCGEF2015-09-01
10886705001927NADEPUY MITEK, LLCGEF2015-09-01
10886705001934NADEPUY MITEK, LLCGEF2015-09-01
10886705002986RIGIDFIXMedos International SàrlGEF2015-09-01
10886705003761GIIDEPUY MITEK, LLCGEF2015-09-01
10886705006809TACITDEPUY MITEK, LLCGEF2015-09-01