FDA UDI
In Commercial Distribution
🇺🇸 United States
BEYOND® BlueSeal® Gingival Protection (5 pack)
DI: 00857848007209
·
Model: BY-PD02205
·
Beyond International Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- BEYOND® BlueSeal® Gingival Protection (5 pack)
- Primary DI
- 00857848007209
- Version / Model
- BY-PD02205
- Company Name
- Beyond International Inc.
- Labeler DUNS
- 080721790
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2022-12-23
- Public Version
- 1
- Public Version Date
- 2023-01-02
- Public Version Status
- New
- Public Device Record Key
- 1a47f8f6-fc6d-4855-862c-3e9d97cb8025
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
- No
- 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 |
|---|---|---|---|---|
| EIE | Dam, Rubber | Dental | 872.6300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57964 | Gingiva bleaching protector | A non-sterile paste or gel-like substance designed to protect a patient's gums from the hydrogen peroxide (H2O2) found in teeth whitening agents used during chairside light-curing bleaching of the teeth. It is typically supplied in a disposable syringe and is applied with an applicator along the gingiva leaving the teeth exposed for treatment. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00857848007209 | GS1 | ||||
| Unit of Use | 00857848007766 | GS1 |