FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TEST-SALTO TALARIS
DI: 93700386926603
·
Model: PPO221
·
TORNIER
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TEST-SALTO TALARIS
- Primary DI
- 93700386926603
- Version / Model
- PPO221
- Company Name
- TORNIER
- Labeler DUNS
- 260324876
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-23
- Public Version
- 1
- Public Version Date
- 2019-12-31
- Public Version Status
- New
- Public Device Record Key
- c15e5652-9bef-4ca8-8cea-1258c0ffdc1f
- Distribution End Date
- 2019-12-23
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JDB | PROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED | Orthopedic | 888.3160 | 2 |
| HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | Orthopedic | 888.3110 | 2 |
| KWI | PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER | Orthopedic | 888.3170 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34202 | Uncoated ankle tibia prosthesis | A sterile implantable device designed to replace the distal tibia (tibial component) as part of a primary ankle joint replacement or prosthesis revision. The device is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws) may be included and implantation is intended to be performed with bone cement. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 93700386926603 | GS1 |
Customer Contacts
- Phone
- +33()0476613500
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Size 1 |