FDA UDI
In Commercial Distribution
🇺🇸 United States
G-COAT PLUS™
DI: 14548161293846
·
Model: 002583
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- G-COAT PLUS™
- Primary DI
- 14548161293846
- Version / Model
- 002583
- Catalog Number
- 002583
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-05
- Public Version
- 1
- Public Version Date
- 2022-08-15
- Public Version Status
- New
- Public Device Record Key
- c15b720e-9403-4b4f-b0b9-b99410953b57
Device Description
G-COAT PLUS™ Starter Kit. Bottle (1 x 4 mL bottle, 20 x dispensing dishes, 50 x micro-tips applicator & 1 x applicator holder)
Device Characteristics
- Single Use
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBD | Coating, filling material, resin | Dental | 872.3310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45294 | Dental restorative material varnish | A liquid substance used to cover dental filling material in the initial setting period after application typically to prevent moisture infiltration (especially when a dental silicate or glass ionomer cement is used as a filling material). The device typically consists of dissolved artificial resins. 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 | 14548161293846 | GS1 |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052462 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 4 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 39 – 77 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 25 Degrees Celsius