FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SALTO TALARIS
DI: 03700386954504
·
Model: LJV300
·
TORNIER
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SALTO TALARIS
- Primary DI
- 03700386954504
- Version / Model
- LJV300
- Company Name
- TORNIER
- Labeler DUNS
- 260324876
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-29
- Public Version
- 3
- Public Version Date
- 2018-09-11
- Public Version Status
- Update
- Public Device Record Key
- cf0bb54a-ced3-40b8-8487-a44fd8438d5b
- Distribution End Date
- 2018-09-11
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 |
|---|---|---|---|---|
| HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER | Orthopedic | 888.3110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48180 | Ankle prosthesis bearing | A sterile implantable device made of polyethylene (PE) designed to articulate the tibial and talar components of a total ankle prosthesis. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03700386954504 | GS1 |
Customer Contacts
- Phone
- +1 (800) 654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Thickness 8 mm | ||
| Device Size Text, specify | Size 01 |