FDA UDI
In Commercial Distribution
🇺🇸 United States
Ramvac
DI: D060C820
·
Model: C82
·
Dentalez Alabama, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ramvac
- Primary DI
- D060C820
- Version / Model
- C82
- Company Name
- Dentalez Alabama, Inc.
- Labeler DUNS
- 806326521
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-05
- Public Version
- 1
- Public Version Date
- 2024-11-13
- Public Version Status
- New
- Public Device Record Key
- b67f2306-e053-4a7a-96db-78f795afec9c
Device Description
COMPRESSOR, 8 USER, 220V
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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NRD | Unit, Operative Dental, Accessories | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42911 | Gas pipeline/supply system air compressor | A mains electricity (AC-powered) device designed to create compressed air, normally of medical grade, and supply it to a hospital or institution's gas pipeline/supply system. Ambient air is filtered, compressed by this device, then cleaned and stored in a pressure tank for delivery upon demand within the facility for medical purposes. Also referred to as a bulk air compressor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D060C820 | HIBCC |