FDA.report

Trident

Primary DI
07613153129752
Brand
Trident
Company
Howmedica Osteonics Corp.
Model
500-11-78K
Catalog number
500-11-78K
Device description
Hemispherical Acetabular Shell
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KWYProsthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613153129752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613153129752076131531297527613153129752

GMDN Terms

TermDefinition
Acetabular shellA sterile, 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Outer Diameter78Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
058311945
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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