| Primary Device ID | 20386040000335 |
| NIH Device Record Key | 290bc4da-3f96-463a-b7d3-a69f39ed76cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COE-COMFORT™ |
| Version Model Number | 341001 |
| Catalog Number | 341001 |
| Company DUNS | 005473608 |
| Company Name | Gc America Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com | |
| Phone | +1(708)597-0900 |
| customerservice@gcamerica.com |
| Storage Environment Temperature | Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 70 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Storage Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10386040000338 [Primary] |
| GS1 | 20386040000335 [Package] Contains: 10386040000338 Package: Carton [6 Units] In Commercial Distribution |
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-07-15 |
| Device Publish Date | 2022-07-07 |
| 10386040006873 | COE-COMFORT™ 1qt liquid |
| 10386040006859 | COE-COMFORT™ 5lb Jar powder |
| 10386040003667 | COE-COMFORT™ 6oz liquid |
| 10386040000840 | COE-COMFORT™ 6oz powder |
| 20386040000335 | COE-COMFORT™ Professional Package (1 x 6oz powder, 1 x 6oz liquid and accessories) |