FDA UDI In Commercial Distribution 🇺🇸 United States

Trident

DI: 04546540237897 · Model: 540-11-64H · Howmedica Osteonics Corp.
Product Codes
10
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Trident
Primary DI
04546540237897
Version / Model
540-11-64H
Catalog Number
540-11-64H
Company Name
Howmedica Osteonics Corp.
Labeler DUNS
058311945
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-09-24
Public Version
4
Public Version Date
2022-08-02
Public Version Status
Update
Public Device Record Key
927a51f7-3882-42ff-8e18-00e2a9e5d100

Device Description

Solid Back Acetabular Shell

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
MR Conditional
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LWJ Prosthesis, hip, semi-constrained, metal/polymer, uncemented
KWY Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
KWZ Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
MEH Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
JDI Prosthesis, hip, semi-constrained, metal/polymer, cemented
MBL Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
KWL Prosthesis, hip, hemi-, femoral, metal
LZO Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
MAY Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
LPH PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

GMDN Terms

Code Name
43167 Acetabular shell

Identifiers

Type ID
Primary 04546540237897

Device Sizes

Type Value Unit Text
Outer Diameter 64.0 Millimeter
Device Size Text, specify Alpha Code: H