FDA UDI
In Commercial Distribution
🇺🇸 United States
Water Unit
DI: 07899581343933
·
Model: Syncrus G2
·
Alliage S/A Indústrias Médico Odontológica
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Water Unit
- Primary DI
- 07899581343933
- Version / Model
- Syncrus G2
- Catalog Number
- 41000008184
- Company Name
- Alliage S/A Indústrias Médico Odontológica
- Labeler DUNS
- 898231451
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-01
- Public Version
- 1
- Public Version Date
- 2025-08-11
- Public Version Status
- New
- Public Device Record Key
- 5e869ab6-a19e-49e0-9921-40a6b7b2fbc0
Device Description
Water Unit Syncrus G2
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| EIA | Unit, Operative Dental | 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 | 07899581343933 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K964619 | 000 |