FDA UDI
In Commercial Distribution
🇺🇸 United States
Facet Screw System
DI: 00840019936231
·
Model: 21-1100-CA
·
PRECISION SPINE, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Facet Screw System
- Primary DI
- 00840019936231
- Version / Model
- 21-1100-CA
- Catalog Number
- 21-1100-CA
- Company Name
- PRECISION SPINE, INC.
- Labeler DUNS
- 079398589
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-08-29
- Public Version
- 1
- Public Version Date
- 2019-09-06
- Public Version Status
- New
- Public Device Record Key
- 285f6325-d680-4686-8efe-b3210aad7042
Device Description
Facet Screw Tray
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| MRW | System, Facet Screw Spinal Device | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63359 | Trans-facet-screw internal spinal fixation system, non-sterile | A non-sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions. This is a single-use device intended to be sterilized prior to use. | Yes | Active |
| 44054 | Orthopaedic surgical procedure kit, non-medicated, reusable | A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840019936231 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130863 | 000 |