FDA UDI
In Commercial Distribution
🇺🇸 United States
Trident
DI: 04546540516848
·
Model: 625-0T-32E
·
Howmedica Osteonics Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Trident
- Primary DI
- 04546540516848
- Version / Model
- 625-0T-32E
- Catalog Number
- 625-0T-32E
- Company Name
- Howmedica Osteonics Corp.
- Labeler DUNS
- 058311945
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-10-03
- Public Version
- 9
- Public Version Date
- 2022-03-14
- Public Version Status
- Update
- Public Device Record Key
- 7c880dd1-839d-406f-9b53-912933807ae7
Device Description
Alpha Code E
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRA | Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48055 | Ceramic acetabular liner | A sterile implantable inner component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of ceramic material (e. g alumina). | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04546540516848 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P000013 | 001 |
| P000013 | 002 |
| P000013 | 003 |
| P000013 | 004 |
| P000013 | 005 |
| P000013 | 006 |
| P000013 | 008 |
| P000013 | 009 |
| P000013 | 010 |
| P000013 | 011 |
| P000013 | 012 |
| P000013 | 013 |
| P000013 | 014 |
| P000013 | 015 |
| P000013 | 016 |
| P000013 | 017 |
| P000013 | 018 |
| P000013 | 019 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Lumen/Inner Diameter | 32.0 | Millimeter | |
| Device Size Text, specify | Degree: 0.0 Degree |