FDA.report

NA

Primary DI
20886705010995
Brand
NA
Company
DEPUY MITEK, LLC
Model
232110
Catalog number
232110
Device description
ACL GRAFT KNIFE 10mm
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDXSCALPEL, ONE-PIECE

Product Code Classifications

CodeDeviceSpecialtyClass
GDXScalpel, One-PieceGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20886705010995PackageGS110In Commercial Distribution
10886705010998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088670501099520886705010995
1088670501099810886705010998

GMDN Terms

TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags

DUNS number
190572854
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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Primary DIBrandModelCatalogPublished
10886705007516FASTIN ETHIBOND2221522221522015-09-01
20886705000903NA2103092103092015-09-01
10886705000951NA2104092104092015-09-01
10886705001088LUPINE ETHIBOND2107102107102015-09-01
10886705001958QUICKANCHOR PANACRYL2121312121312015-09-01
10886705001989GII QUICKANCHOR PANACRYL2121342121342015-09-01
10886705001996QUICKANCHOR PANACRYL2121352121352015-09-01
10886705002047ETHIBOND2123102123102015-09-01
20886705002051ETHIBOND2123152123152015-09-01
10886705002061GII ETHIBOND2124502124502015-09-01
10886705002184PANALOK QUICKANCHOR PANACRYL2127322127322015-09-01
10886705002191PANALOK QUICKANCHOR ORTHOCORD2127332127332015-09-01
20886705002204GII PANACRYL2127342127342015-09-01
10886705007493FASTIN ETHIBOND2221302221302015-09-01
10886705007509FASTIN ETHIBOND2221402221402015-09-01
20886705008190FASTIN ETHIBOND2225302225302015-09-01
20886705008213FASTIN ETHIBOND2225522225522015-09-01
10886705008575QUICKANCHOR ORTHOCORD2229792229792015-09-01
10886705008605ORTHOCORD2229822229822015-09-01
10886705017904BRISTOW LATARJET2852202852202015-09-01

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