FDA.report

BHR

Primary DI
00885556070710
Brand
BHR
Company
Smith & Nephew, Inc.
Model
74122542
Catalog number
74122542
Device description
HEMI HEAD 42MM
Published
2015-10-23
Public version status
Update
Distribution status
Not 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
KWLProsthesis, hip, hemi-, femoral, metal

Product Code Classifications

CodeDeviceSpecialtyClass
KWLProsthesis, Hip, Hemi-, Femoral, MetalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00885556070710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556070710008855560707108855560707100885556070710

GMDN Terms

TermDefinition
Metallic femoral head prosthesisA sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal (e.g., titanium alloy). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip arthroplasty. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
109903521
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

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00885556919750Real IntelligenceROB30004ROB300042026-03-10
00885556919767Real IntelligenceROB30005ROB300052026-03-10
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00885556924198Real IntelligenceROB30026ROB300262026-03-10
00885556924204Real IntelligenceROB30021ROB300212026-03-10
00885556924211Real IntelligenceROB30027ROB300272026-03-10
00885556924228Real IntelligenceROB30022ROB300222026-03-10
00885556924235Real IntelligenceROB30023ROB300232026-03-10
00885556924242Real IntelligenceROB30024ROB300242026-03-10
00885556924266Real IntelligenceROB30028ROB300282026-03-10
00885556924273Real IntelligenceROB30020ROB300202026-03-10
00885556924297Real IntelligenceROB30880ROB308802026-03-10
20885556924307NAROB30031ROB300312026-03-10
00885556787786NA74034136740341362026-02-20
00885556884027NA74038834740388342026-02-20
00885556884034NA74038835740388352026-02-20
00885556884140NA74038846740388462026-02-20

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00887868551611StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551628StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551659StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551666StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
00887868551680StageOne SelectBiomet Orthopedics, LLCKWL2026-03-17
08031497003955Interspace GV Hip Spacer 46TECRES SPAKWL2026-02-11
08031497003962Interspace GV Hip Spacer 54TECRES SPAKWL2026-02-11
08031497003979Interspace GV Hip Spacer 60TECRES SPAKWL2026-02-11
08031497003986Interspace GV Hip Spacer 46 XLTECRES SPAKWL2026-02-11
08031497003993Interspace GV Hip Spacer 54 XLTECRES SPAKWL2026-02-11
08031497004006Interspace GV Hip Spacer 60 XLTECRES SPAKWL2026-02-11
00822409123445TrivictaOrtho Development CorporationKWL2024-04-01
00822409123452TrivictaOrtho Development CorporationKWL2024-04-01
00822409123483TrivictaOrtho Development CorporationKWL2024-04-01
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00822409123766TrivictaOrtho Development CorporationKWL2024-04-01
00822409123827TrivictaOrtho Development CorporationKWL2024-04-01
00822409123834TrivictaOrtho Development CorporationKWL2024-04-01
00822409123865TrivictaOrtho Development CorporationKWL2024-04-01
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00814193025982SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193025999SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193026002SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
00814193026019SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
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00814193026040SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14
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00814193026064SYNOVO HIP COMPONENTSSynovo ProductionKWL2024-03-14