FDA.reportPublic FDA data

EMPHASYS

Primary DI
10603295532026
Brand
EMPHASYS
Company
DEPUY (IRELAND)
Model
4800-50-040
Catalog number
480050040
Device description
EMPHASYS ACETABULAR ALUMINUM TRAY STRAIGHT INSTRUMENT AND QUICKSET REAMER 44mm - 55mm
Published
2022-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295532026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329553202610603295532026

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
989365556
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295079941AML EXCEL2001-42-0002001420002018-09-24
10603295080008AML EXCEL2001-47-0002001470002018-09-24
10603295080015AML EXCEL2001-48-0002001480002018-09-24
10603295080022AML EXCEL2001-49-0002001490002018-09-24
10603295080145NA2001-80-5012001805012018-09-24
10603295080770NA2002-25-0002002250002018-09-24
10603295080787NA2002-27-0002002270002018-09-24
10603295080794NA2002-31-0002002310002018-09-24
10603295082057TRI-LOCK2012-03-0052012030052018-09-24
10603295082064TRI-LOCK2012-03-0102012030102018-09-24
10603295082071TRI-LOCK2012-03-0202012030202018-09-24
10603295082088TRI-LOCK2012-03-0302012030302018-09-24
10603295082095TRI-LOCK2012-03-0402012030402018-09-24
10603295082101TRI-LOCK2012-03-0502012030502018-09-24
10603295082118TRI-LOCK2012-03-0602012030602018-09-24
10603295082125TRI-LOCK2012-03-0702012030702018-09-24
10603295082132TRI-LOCK2012-03-0802012030802018-09-24
10603295082149TRI-LOCK2012-03-0902012030902018-09-24
10603295082156TRI-LOCK2012-03-1002012031002018-09-24
10603295082163TRI-LOCK2012-03-1102012031102018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
EZPF85140000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85142100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85142200HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85145000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85150000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85195650HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85312070HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-12
EZPF85180000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180020HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180030HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180050HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85180100HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181030HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181050HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85181090HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85182000HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85182010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85182030HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09
EZPF85182040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHFSM2022-12-09