FDA.report

EMPHASYS

Primary DI
10603295500568
Brand
EMPHASYS
Company
DEPUY (IRELAND)
Model
4710-44-300
Catalog number
471044300
Device description
EMPHASYS ACETABULAR SHELL THREE-HOLE 44MM CEMENTLESS
Published
2022-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10603295500568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1060329550056810603295500568

GMDN Terms

TermDefinition
Acetabular shellAn implantable component of a two-piece acetabulum prosthesis that forms the outer portion of the prosthesis, fixed to the pelvis to provide a base for the inner portion (acetabular liner). It is made of metal, and is fixed with bone cement and/or fixation devices.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
989365556
Device count
1
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10603295085980GLOBAL UNITE2100-70-2502100702502018-06-15
10603295088196GLOBAL ADVANTAGE2128-02-0502128020502018-09-24
10603295130192ATTUNE2544-01-0032544010032018-09-24
10603295130208ATTUNE2544-01-0042544010042018-09-24
10603295130222ATTUNE2544-01-0062544010062018-09-24
10603295395423ATTUNE2544-01-0092544010092018-09-24
10603295431275DEPUY REACH9505-05-1349505051342018-09-24
10603295431596DEPUY REACH9505-05-1359505051352018-09-24
10603295440222ATTUNE2546-00-4242546004242016-12-05
10603295443780ATTUNE2544-91-0012544910012020-06-11
10603295443797ATTUNE2544-91-0022544910022020-06-11
10603295443803ATTUNE2544-91-0032544910032020-06-11
10603295443810ATTUNE2544-91-0042544910042020-06-11
10603295451297ATTUNE2546-00-4162546004162016-12-05
10603295493549ATTUNE2544-11-0032544110032017-04-10
10603295496229ATTUNE2546-00-5162546005162018-01-24
10603295543879RECLAIM74-1000-1157410001152026-01-23
10603295543916RECLAIM74-1000-1207410001202026-01-23
10603295503309ATTUNE1506-61-3101506613102026-01-13
10603295503316ATTUNE1506-61-3201506613202026-01-13

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