FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Pro-V C&B Bleach 50ml Syr. Refill Pkg
DI: D757H403BLP1
·
Model: H-403BLP
·
BISCO INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Pro-V C&B Bleach 50ml Syr. Refill Pkg
- Primary DI
- D757H403BLP1
- Version / Model
- H-403BLP
- Catalog Number
- H-403BLP
- Company Name
- BISCO INC.
- Labeler DUNS
- 053529939
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-21
- Public Version
- 4
- Public Version Date
- 2021-03-15
- Public Version Status
- Update
- Public Device Record Key
- 9924dd01-2ecf-4d54-b832-fddbb5116df0
- Distribution End Date
- 2020-12-31
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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 |
|---|---|---|---|---|
| EBG | Crown And Bridge, Temporary, Resin | Dental | 872.3770 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34976 | Preformed dental crown, temporary | A prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D757H403BLP1 | HIBCC |
Customer Contacts
- Phone
- +1(847)534-6000
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 25 Degrees Celsius