FDA UDI
In Commercial Distribution
🇺🇸 United States
Advance Dental Products
DI: 10850002458166
·
Model: 469053
·
The Atlanta Dental Supply Company
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
250
Basic Information
- Brand Name
- Advance Dental Products
- Primary DI
- 10850002458166
- Version / Model
- 469053
- Company Name
- The Atlanta Dental Supply Company
- Labeler DUNS
- 033505389
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 250
- Record Status
- Published
- Publish Date
- 2023-02-10
- Public Version
- 1
- Public Version Date
- 2023-02-20
- Public Version Status
- New
- Public Device Record Key
- 9ed84982-3ebd-4f8e-80da-a0c86b865381
Device Description
Advance Air/Water Syringe Tips
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| EIB | Syringe, irrigating (dental) | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65430 | Dental delivery system irrigation handpiece tip | A rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20850002458163 | GS1 | 16 | In Commercial Distribution | ||
| Primary | 10850002458166 | GS1 | ||||
| Unit of Use | 00850002458169 | GS1 |