FDA UDI
In Commercial Distribution
🇺🇸 United States
3D Dental- Bioviva
DI: 00817169021964
·
Model: BHG
·
3D DENTAL DESIGNS AND DEVELOPMENT, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- 3D Dental- Bioviva
- Primary DI
- 00817169021964
- Version / Model
- BHG
- Company Name
- 3D DENTAL DESIGNS AND DEVELOPMENT, LLC
- Labeler DUNS
- 080194935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-30
- Public Version
- 2
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- 4c0501fd-1c05-434f-8711-02e31bbd469c
Device Description
Bioviva Soluble Dental Hemostatic Gauze
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63636 | General oral wound dressing, non-animal-derived, sterile | A sterile device intended to be used as a protective cover for the general oral mucosa to treat surgical or traumatic wounds/lesions in the mouth. It consists primarily of one or more plant-derived and/or (bio)synthetic compound(s) and is supplied in various forms (e.g., plug, sheet, gel, fluid, spray) for use in the home or a clinical setting. After application, this device cannot be reused. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817169021964 | GS1 |