FDA UDI
In Commercial Distribution
🇺🇸 United States
NOU-CLEAN SPRAY
DI: ENOU19849
·
Model: 1984
·
Nouvag AG
Product Codes
7
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NOU-CLEAN SPRAY
- Primary DI
- ENOU19849
- Version / Model
- 1984
- Company Name
- Nouvag AG
- Labeler DUNS
- 480610476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-15
- Public Version
- 1
- Public Version Date
- 2018-09-17
- Public Version Status
- New
- Public Device Record Key
- 3b2510ed-c38e-4fdf-98b0-80c8ef9c9470
Device Description
Cleaning spray for Instruments and Motors 500ml
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GFD | Dermatome | General, Plastic Surgery | 878.4820 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | General, Plastic Surgery | 878.4820 | 1 |
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | 878.4820 | 1 |
| HBC | Motor, Drill, Electric | Neurology | 882.4360 | 2 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | Ear, Nose, Throat | 874.4250 | 2 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | Dental | 872.4200 | 1 |
| DZI | Drill, Bone, Powered | Dental | 872.4120 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15772 | Surgical instrument maintenance lubricant | A non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | ENOU19849 | HIBCC |
Customer Contacts
- Phone
- +41718466600
- [email protected]