FDA UDI
In Commercial Distribution
🇺🇸 United States
MD 30
DI: ENOU33300
·
Model: 3330
·
Nouvag AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MD 30
- Primary DI
- ENOU33300
- Version / Model
- 3330
- Company Name
- Nouvag AG
- Labeler DUNS
- 480610476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5e515368-11ef-48d2-8b5c-26e7f2260c07
Device Description
Dental implant motor system
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| DZI | Drill, Bone, Powered | Dental | 872.4120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38763 | Remotely-driven dental drilling system motor | A mains electricity (AC-powered) compact motor used in conjunction with a spinning cable (e.g., a Bowden cable) to provide remote rotational power from the motor to a dental drill handpiece. This device is line-powered and cannot be sterilized. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ENOU33300 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042434 | 000 |