FDA UDI
In Commercial Distribution
🇺🇸 United States
Triathlon
DI: 07613327014754
·
Model: 5550-G-339
·
Howmedica Osteonics Corp.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Triathlon
- Primary DI
- 07613327014754
- Version / Model
- 5550-G-339
- Catalog Number
- 5550-G-339
- 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
- 2022-06-02
- Public Version Status
- Update
- Public Device Record Key
- c40dab6b-77fa-4ed7-9719-f9794b1b859a
Device Description
Symmetric Patella
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
- 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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MBH | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER | Orthopedic | 888.3565 | 2 |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER | Orthopedic | 888.3560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34199 | Polyethylene patella prosthesis | An implantable device made of polyethylene (PE) intended to fully or partially replace the patella (kneecap) as part of a bicondylar knee joint replacement (primary or revision). It is designed to articulate with a prosthetic distal femoral component by attachment to the back of the natural patella with or without bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327014754 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Diameter: 33.0 Millimeter | ||
| Device Size Text, specify | Type: Symetric | ||
| Device Size Text, specify | Thickness: 9.0 Millimeter |