FDA UDI
In Commercial Distribution
🇺🇸 United States
A-dec
DI: 10194665000073
·
Model: 362
·
A-DEC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- A-dec
- Primary DI
- 10194665000073
- Version / Model
- 362
- Catalog Number
- 362
- Company Name
- A-DEC, INC.
- Labeler DUNS
- 009617473
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-07
- Public Version
- 2
- Public Version Date
- 2023-04-26
- Public Version Status
- Update
- Public Device Record Key
- 9b65c12b-6034-4cbe-b6bc-aa76330f3a8e
Device Description
A-dec 362 Support System
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 |
|---|---|---|---|---|
| EBR | Unit, Suction Operatory | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34983 | Dental cuspidor | A device shaped as a round bowl (a vessel), into which the patient will spit out the contents of their mouth during and after dental procedures. This vessel is usually a component of the dental delivery system and will typically have a water supply to allow the filling of a drinking vessel with warmed water for the patient to rinse out their mouth and provide the flushing of the cuspidor to wash away the waste (e.g., blood, tooth and material debris). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10194665000073 | GS1 |