FDA UDI
In Commercial Distribution
🇺🇸 United States
Tornier Latitude
DI: 00846832015351
·
Model: 9030295
·
TORNIER, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Tornier Latitude
- Primary DI
- 00846832015351
- Version / Model
- 9030295
- Catalog Number
- 9030295
- Company Name
- TORNIER, INC.
- Labeler DUNS
- 968990812
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-09
- Public Version
- 1
- Public Version Date
- 2022-08-17
- Public Version Status
- New
- Public Device Record Key
- 2ddd6620-c310-41ec-8a66-7b10b80a22f9
Device Description
ULNAR REVISION STEM TRIAL
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXH | Orthopedic manual surgical instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58751 | Elbow ulna prosthesis trial | A copy of a final ulna prosthesis designed to be used for trial reductions during elbow arthroplasty to judge the correct sizing, length, and range of motion of the final prosthesis to be implanted. It is one of a set, or a set, of graduated sizes and is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00846832015351 | GS1 |
Customer Contacts
- Phone
- +1(888)494-7950
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 125 | Millimeter | |
| Device Size Text, specify | Size MEDIUM |