FDA.reportPublic FDA data

Hip Instruments

Primary DI
07630040734271
Brand
Hip Instruments
Company
Medacta International SA
Model
01.15.10.0004
Device description
MAQUET standard adaptor
Published
2020-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FWXTable, Operating-Room, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWXTable, Operating-Room, MechanicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630040734271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630040734271076300407342717630040734271

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
488227125
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630542788314AMIStem-P13.000092026-06-08
07630542788321AMIStem-P13.000102026-06-08
07630542788338AMIStem-P13.000112026-06-08
07630542788345AMIStem-P13.000122026-06-08
07630542788352AMIStem-P13.000132026-06-08
07630542788369AMIStem-P13.000142026-06-08
07630542788376AMIStem-P13.000152026-06-08
07630971243637AMIStem-P Short Neck01.18.4592020-01-29
07630971243644AMIStem-P Short Neck01.18.4602020-01-29
07630971243651AMIStem-P Short Neck01.18.4612020-01-29
07630971243668AMIStem-P Short Neck01.18.4622020-01-29
07630971243675AMIStem-P Short Neck01.18.4632020-01-29
07630971243682AMIStem-P Short Neck01.18.4642020-01-29
07630971243699AMIStem-P Short Neck01.18.4652020-01-29
07630971243705AMIStem-P Short Neck01.18.4662020-01-29
07630971243712AMIStem-P Short Neck01.18.4672020-01-29
07630971243729AMIStem-P Short Neck01.18.4682020-01-29
07630971243736AMIStem-P Short Neck01.18.4692020-01-29
07630971243743AMIStem-P Short Neck01.18.4702020-01-29
07630971243750AMIStem-P Short Neck01.18.4712020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B773KMOPT0KLYOKLYO MEDICAL SYSTEMS INC.FWX2024-02-22
04250435526996DORO® Lubricant HP500 Black Forest Medical GmbHFWX2023-07-26
04250435528129DORO® Lubricant HP500 Black Forest Medical GmbHFWX2023-07-26
B773KLTEM77KLYOKLYO MEDICAL SYSTEMS INC.FWX2023-05-24
07630040744966Hip InstrumentsMedacta International SAFWX2021-11-10
07630040728027Hip InstrumentsMedacta International SAFWX2021-05-10
07630040754521HIP InstrumentsMedacta International SAFWX2020-12-09
07630040754538HIP InstrumentsMedacta International SAFWX2020-12-09
07630040754545HIP InstrumentsMedacta International SAFWX2020-12-09
07630040754552HIP InstrumentsMedacta International SAFWX2020-12-09
07630040754569HIP InstrumentsMedacta International SAFWX2020-12-09
07630040754576HIP InstrumentsMedacta International SAFWX2020-12-09
07630040754583HIP InstrumentsMedacta International SAFWX2020-12-09
07630040754590HIP InstrumentsMedacta International SAFWX2020-12-09
07630040754606HIP InstrumentsMedacta International SAFWX2020-12-09
07630040736206HIP InstrumentsMedacta International SAFWX2020-11-04
07630040735971Hip InstrumentsMedacta International SAFWX2020-08-06
07630040735988Hip InstrumentsMedacta International SAFWX2020-08-06
07630040735759Hip InstrumentsMedacta International SAFWX2020-07-30
07630040735766Hip InstrumentsMedacta International SAFWX2020-07-30
07630040735797Hip InstrumentsMedacta International SAFWX2020-07-30
07630040735803Hip InstrumentsMedacta International SAFWX2020-07-30
07630040735834Hip InstrumentsMedacta International SAFWX2020-07-30
07630040735858Hip InstrumentsMedacta International SAFWX2020-07-30
07630040735742Hip InstrumentsMedacta International SAFWX2020-07-09
07630040735896Hip InstrumentsMedacta International SAFWX2020-07-09
07630040735735Hip InstrumentsMedacta International SAFWX2020-07-07
07630040735773Hip InstrumentsMedacta International SAFWX2020-07-07
07630040735810Hip InstrumentsMedacta International SAFWX2020-07-07
07630040735841Hip InstrumentsMedacta International SAFWX2020-07-07