FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NANO Micromotor + Cable
DI: J00717005010011
·
Model: 1700501
·
Bien-Air Surgery SA
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NANO Micromotor + Cable
- Primary DI
- J00717005010011
- Version / Model
- 1700501
- Catalog Number
- 1700501-001
- Company Name
- Bien-Air Surgery SA
- Labeler DUNS
- 481597719
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-07
- Public Version
- 3
- Public Version Date
- 2023-02-13
- Public Version Status
- Update
- Public Device Record Key
- 7759993f-faa1-44c5-b579-1c1eba4c0e36
- Distribution End Date
- 2023-02-10
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| HBC | Motor, Drill, Electric | Neurology | 882.4360 | 2 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | Neurology | 882.4310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33541 | Bone/joint surgical power tool motor, electric | A hand-held, electrically-powered component of a surgical power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy to perform a variety of non-dental surgical procedures such as drilling or sawing of bones and tough tissues. It is designed to accept a motorless handpiece component/attachment (not included) and it is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It may be a micro or macro style device, be cannulated to permit use of a guidewire, include a rechargeable battery, and might be operated with a hand- or foot-switch. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | J00717005010011 | HIBCC |