FDA UDI
In Commercial Distribution
🇺🇸 United States
Britedent
DI: D974BSIS12CC1
·
Model: BSI-S12CC
·
Bright Supply, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Britedent
- Primary DI
- D974BSIS12CC1
- Version / Model
- BSI-S12CC
- Company Name
- Bright Supply, Inc.
- Labeler DUNS
- 124117012
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2020-11-26
- Public Version
- 1
- Public Version Date
- 2020-12-04
- Public Version Status
- New
- Public Device Record Key
- 969466d8-894a-4ac5-bff3-10de8e432df5
Device Description
Utility syringe curved 12cc
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
- MR Safe
- 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 |
|---|---|---|---|---|
| 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 | D974BSIS12CC2 | HIBCC | Bag | 20 | In Commercial Distribution | |
| Primary | D974BSIS12CC1 | HIBCC | ||||
| Unit of Use | D974BSIS12CC0 | HIBCC |