FDA UDI
In Commercial Distribution
🇺🇸 United States
PRECICE® Trauma Nail System
DI: 00812258028053
·
Model: TEC1-010
·
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PRECICE® Trauma Nail System
- Primary DI
- 00812258028053
- Version / Model
- TEC1-010
- Catalog Number
- TEC1-010
- Company Name
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Labeler DUNS
- 837845234
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-10
- Public Version
- 5
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- 413f3b7e-9009-48d0-82f4-0566e53040bd
Device Description
End Cap for PRECICE Trauma Intramedullary Nail System Implant
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 Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46139 | Bone nail end-cap | A small, rounded plug, cover or threaded screw designed to seal the proximal end of an orthopaedic nail implanted to treat a damaged bone (e.g., a fracture), to prevent healing tissue from growing into the hollow nail and to facilitate nail extraction. It is typically made of metal [e.g., high-grade stainless steel, titanium (Ti)], and is available in a variety of sizes. It may also be used to securely lock the most proximal oblique locking screw or help extend the length of a nail when necessary. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812258028053 | GS1 |
Customer Contacts
- Phone
- 855-435-5477
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160267 | 000 |