FDA UDI
In Commercial Distribution
🇺🇸 United States
External Fixator Drill brace
DI: 07640136270446
·
Model: 5010-1000
·
GEXFIX SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- External Fixator Drill brace
- Primary DI
- 07640136270446
- Version / Model
- 5010-1000
- Company Name
- GEXFIX SA
- Labeler DUNS
- 482579716
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 8db5cfd5-e7ab-40b9-bf2f-2d150c78f7d5
Device Description
Reusable external orthopaedic fixation system instrument intended for implantation and/or tightening.
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
- 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 |
|---|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44758 | General external orthopaedic fixation system implantation kit, reusable | A collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spine, pelvis, craniomaxillofacial areas). It is a non-dedicated device that includes various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, cutters, screwdrivers, guides, tighteners) that are specific to the fixation system applied; the implant(s) is not included. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640136270446 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052605 | 000 |