FDA.reportPublic FDA data

NA

Primary DI
10886705009930
Brand
NA
Company
DEPUY MITEK, LLC
Model
228000
Catalog number
228000
Device description
MENISCAL APPLIER
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
10886705009930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500993010886705009930

GMDN Terms#

Term, Definition table
TermDefinition
Suturing unit, single-useA non-powered, hand-held device intended to pass sutures or a needle/suture assembly through tissues/prosthetic materials to facilitate suturing during an endoscopic and/or open surgical procedure. It typically consists of a shaft with hooks, catches, clasps, or forceps-like jaws at the distal end, and a proximal handle with controls. It typically has a pointed/cutting component to create a suture tunnel, and is loaded with the sutures or the suture is inserted through the shaft; it may in addition knot and/or cut the sutures as they are placed. This is a single-use device.

Sterilization Methods#

Method table
Method

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
Expiration date on label
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
10886705010059NADEPUY MITEK, LLCGEF2015-09-01
10886705001910GIIDEPUY 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