FDA UDI
In Commercial Distribution
🇺🇸 United States
Dynamic Axial Fixator
DI: 18033509856006
·
Model: 1
·
ORTHOFIX SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Dynamic Axial Fixator
- Primary DI
- 18033509856006
- Version / Model
- 1
- Catalog Number
- 99-1-1101101
- Company Name
- ORTHOFIX SRL
- Labeler DUNS
- 438793622
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-01
- Public Version
- 5
- Public Version Date
- 2020-07-23
- Public Version Status
- Update
- Public Device Record Key
- 2a093975-412b-4864-9e1a-ab41bc8bc9b8
Device Description
CANNULATED DRILL BIT D.3,2 MM L.200 MM TIN COATED - QUICK CONNECT STERILE
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| JDW | Pin, Fixation, Threaded | Orthopedic | 888.3040 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43390 | Fluted surgical drill bit, single-use | A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18033509856006 | GS1 |
Customer Contacts
- Phone
- +039456719000
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955848 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 200 | Millimeter | |
| Outer Diameter | 3.2 | Millimeter |