FDA UDI
In Commercial Distribution
🇺🇸 United States
COE-COMFORT™
DI: 10386040006873
·
Model: 341092
·
Gc America Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- COE-COMFORT™
- Primary DI
- 10386040006873
- Version / Model
- 341092
- Catalog Number
- 341092
- Company Name
- Gc America Inc.
- Labeler DUNS
- 005473608
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-07
- Public Version
- 1
- Public Version Date
- 2022-07-15
- Public Version Status
- New
- Public Device Record Key
- 74f6a03e-5fa1-4635-8447-32d972f7602e
Device Description
COE-COMFORT™ 1qt liquid
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 |
|---|---|---|---|---|
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17610 | Denture reliner, soft, professional | A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). 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 | 10386040006873 | GS1 |
Customer Contacts
- Phone
- +1(708)597-0900
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K070698 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Quart |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 21 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 70 – 77 Degrees Fahrenheit