FDA.reportPublic FDA data

EMPHASYS

Primary DI
10603295513698
Brand
EMPHASYS
Company
DEPUY (IRELAND)
Model
4840-01-100
Catalog number
484001100
Device description
EMPHASYS FEMORAL BROACH SIZE 1
Published
2021-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QBOInstruments designed for press-fit osteochondral implants

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBOInstruments Designed For Press-Fit Osteochondral ImplantsOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295513698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329551369810603295513698

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic broachA surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. 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
989365556
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
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
10810128461495CARTIHEAL AGILI-C Disposable Toolset 7.5T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
10810128461501CARTIHEAL AGILI-C Disposable Toolset 10T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
10810128461518CARTIHEAL AGILI-C Disposable Toolset 10T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONQBO2025-08-05
00840124520493FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2025-05-16
00840124514195PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-28
00840124514201FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-10-28
00840124512825PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512832PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512849PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512856PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124512863PolyPrepFUSION ORTHOPEDICS, LLCQBO2024-10-07
00840124513853FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-09-23
00840124513884FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCQBO2024-09-23
00860010346907Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346914Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346921Instrumentation Set - for Use with Osteochondral Allograft, PRE-CUT CORESwami Medical, LLCQBO2024-08-22
00860010346938Sizer Set - for Use with Osteochondral Allograft, PRE-CUT CORE Swami Medical, LLCQBO2024-08-22
07290019087199Agili-C Surgical Toolset Full Sterilization TrayCARTIHEAL (2009) LTDQBO2023-12-01
07290019087045Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087052Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087069Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087076Agili-C Mini Disposable ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087083Agili-C Sterilization CaseCARTIHEAL (2009) LTDQBO2022-10-04
07290019087090Agili-C Cartilage Cutter CARTIHEAL (2009) LTDQBO2022-10-04
07290019087106Agili-C Cartilage Cutter CARTIHEAL (2009) LTDQBO2022-10-04
07290019087113Agili-C Quick Connect Handle CARTIHEAL (2009) LTDQBO2022-10-04
07290019087120Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087137Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087144Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04
07290019087151Agili-C ToolsetCARTIHEAL (2009) LTDQBO2022-10-04