FDA UDI
In Commercial Distribution
🇺🇸 United States
PRECICE® Trauma Nail System
DI: 00812258027520
·
Model: CDT12.5-30T240
·
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
- 00812258027520
- Version / Model
- CDT12.5-30T240
- Catalog Number
- CDT12.5-30T240
- Company Name
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Labeler DUNS
- 837845234
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-20
- Public Version
- 4
- Public Version Date
- 2022-12-08
- Public Version Status
- Update
- Public Device Record Key
- 015b5cb6-0479-458f-ba62-dbdd1499b74a
Device Description
Orthopedic trauma intramedullary rod, antegrade tibia 10° bend, 12.5 mm diameter, 240 mm length
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 |
|---|---|---|---|---|
| 38152 | Tibia nail | A rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model and possess components to assist fixation of more proximal or distal conditions. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812258027520 | GS1 |
Customer Contacts
- Phone
- 855-435-5477
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162927 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 12.5 | Millimeter |