FDA UDI
In Commercial Distribution
🇺🇸 United States
PRECICE® System
DI: 00887517937735
·
Model: TSA4.5-032.5
·
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PRECICE® System
- Primary DI
- 00887517937735
- Version / Model
- TSA4.5-032.5
- Catalog Number
- TSA4.5-032.5
- Company Name
- NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
- Labeler DUNS
- 837845234
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-15
- Public Version
- 2
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 9394ba62-6343-4954-83fe-f2379ee3c5fe
Device Description
Locking Screw, 4.5x32.5mm Fully Threaded
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
- 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 |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | Orthopedic | 888.3020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63367 | Long bone distraction nail, magnetic | An implantable device in the form of a rod, capable of adjusting in length, designed to be inserted into the medullary cavity of a long bone to hold the ends of a fractured bone in position to promote healing, or to support the bone in the presence of a pathological condition, or for limb lengthening procedures (not related to arthrodesis); each rod (nail) is specific to a particular long bone (e.g., femur, humerus, tibia). It consists of telescoping rods connected to the bone by locking screws, which have one or more integrated magnets that move in response to a noninvasive magnetic control device to adjust length. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00887517937735 | GS1 |
Customer Contacts
- Phone
- 855-435-5477
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172628 | 000 |