FDA UDI
In Commercial Distribution
🇺🇸 United States
Vilex Fibula Drill
DI: 00841731122001
·
Model: ZF-DRLL-25
·
VILEX LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vilex Fibula Drill
- Primary DI
- 00841731122001
- Version / Model
- ZF-DRLL-25
- Catalog Number
- ZF-DRLL-25
- Company Name
- VILEX LLC
- Labeler DUNS
- 117502293
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-14
- Public Version
- 5
- Public Version Date
- 2020-05-27
- Public Version Status
- Update
- Public Device Record Key
- c38c32fb-e53d-44ee-ada6-ec9a74ac72fc
Device Description
Drill, Fibula 2.5x245mm
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| HTW | Bit, Drill | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47563 | Fluted surgical drill bit, single-use, non-sterile | A non-sterile 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, its shaft is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device intended to be sterilized prior to use. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841731122001 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151456 | 000 |