| Primary Device ID | 10386040004794 |
| NIH Device Record Key | 116e1845-335b-4bbe-b1bd-0923a8cbaadc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COE HYDROPHILIC GEL™ |
| Version Model Number | 124125 |
| Catalog Number | 124125 |
| 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 |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| Weight | 5 Pound |
| 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 | 10386040004794 [Primary] |
| ELW | MATERIAL, IMPRESSION |
| 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 |
| 10386040004794 | COE HYDROPHILIC GEL™ Fast set, cherry, 5 x 5lb powder (25lb total) |
| 20386040004784 | COE HYDROPHILIC GEL™ Fast set, cherry, 1 x 1lb powder and 1 x scoop |
| 20386040004777 | COE HYDROPHILIC GEL™ Normal set, cherry, 1 x 1lb powder and 1 x scoop |