FDA UDI
In Commercial Distribution
🇺🇸 United States
Renovo Life, LLC
DI: M734RNL3102500
·
Model: RNL-310-250
·
RENOVO LIFE LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Renovo Life, LLC
- Primary DI
- M734RNL3102500
- Version / Model
- RNL-310-250
- Catalog Number
- RNL-310-250
- Company Name
- RENOVO LIFE LLC
- Labeler DUNS
- 059066475
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-11-14
- Public Version
- 3
- Public Version Date
- 2018-11-22
- Public Version Status
- Update
- Public Device Record Key
- e2f30cc0-8b9e-4023-96ae-19a882fe2cb0
Device Description
2.5mm Drill Bit, Quick Connect, 110mm length
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 | M734RNL3102500 | HIBCC |
Customer Contacts
- Phone
- 1-844-663-3542
- [email protected]