FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Gingivamoll
DI: 00842092155820
·
Model: 0900001
·
Preat Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gingivamoll
- Primary DI
- 00842092155820
- Version / Model
- 0900001
- Catalog Number
- 0900001
- 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
- 90b6023e-e1fe-4b85-8691-a32cd71b4666
- Distribution End Date
- 2022-10-28
Device Description
Gingivamoll Starter Kit. Kit contains . 1 Gingivamoll Opaque 4g (00842092155752). 1 Gingivamoll Pink 2.5g (00842092155769). 1 Gingivamoll Light Pink 2.5g (00842092155776). 1 Gingivamoll Stain Liquid 5mL (00842092155783). 1 Gingivamoll Protective Lacquer 5mL (00842092155790). 1 Gingivamoll Red Stain 2g (00842092155806). 1 Gingivamoll Blue Stain 2g (00842092155813)
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 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 | 00842092155820 | GS1 |
Customer Contacts
- Phone
- +1(800) 232-7732
- [email protected]