FDA UDI
In Commercial Distribution
🇺🇸 United States
SAFE DENT
DI: 00810339030452
·
Model: A9013
·
BGSS Company Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- SAFE DENT
- Primary DI
- 00810339030452
- Version / Model
- A9013
- Company Name
- BGSS Company Inc.
- Labeler DUNS
- 828474952
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2024-05-01
- Public Version
- 1
- Public Version Date
- 2024-05-09
- Public Version Status
- New
- Public Device Record Key
- 9a94c549-c243-4c6d-9dc3-24737f773118
Device Description
A9013 5ML DISPOSABLE IMPRESSION SYRINGE BAG 50PCS
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
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EID | Syringe, Restorative And Impression Material | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58894 | Dental impression material syringe, single-use | A non-sterile, hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient?s mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810339030469 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00810339030452 | GS1 | ||||
| Unit of Use | 00810339030445 | GS1 |