FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Gingivamoll
DI: 00842092112328
·
Model: 0900003
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gingivamoll
- Primary DI
- 00842092112328
- Version / Model
- 0900003
- Catalog Number
- 0900003
- Company Name
- Preat Corporation
- Labeler DUNS
- 117776048
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-25
- Public Version
- 4
- Public Version Date
- 2024-01-11
- Public Version Status
- Update
- Public Device Record Key
- 268e0c81-22bc-4b47-b988-552f722d6f1f
- Distribution End Date
- 2022-10-28
Device Description
Gingivamoll Model with Mask
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NOK | MATERIAL, EXTERNAL AESTHETIC RESTORATION, NO ADHESIVE | General, Plastic Surgery | 878.3800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63592 | Dental acrylic resin kit | A collection of non-sterile substances intended for professional use during dental restoration and prosthesis installation/repair which includes acrylic resin material (without hardening fillers/materials) and additional materials to support restoration (e.g., etching solution, bonding agent, primer, prosthesis bonding agents, unfilled resin sealant/coating agents), and may include dedicated disposable devices associated with application; it does not include non-resin-based cements nor dental prostheses. 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 | 00842092112328 | GS1 |
Customer Contacts
- Phone
- +1(800) 232-7732
- [email protected]