| Primary Device ID | 00614138101623 |
| NIH Device Record Key | 8d68b594-b9c3-4bc2-b7af-dd23015a1fe1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Comfo-Tex™ |
| Version Model Number | 0131-6S |
| Catalog Number | 0131-6S |
| Company DUNS | 047580212 |
| Company Name | TETRA MEDICAL SUPPLY CORP. |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 18006214041 |
| sales@tetramed.com | |
| Phone | 18006214041 |
| sales@tetramed.com | |
| Phone | 18006214041 |
| sales@tetramed.com | |
| Phone | 18006214041 |
| sales@tetramed.com | |
| Phone | 18006214041 |
| sales@tetramed.com | |
| Phone | 18006214041 |
| sales@tetramed.com | |
| Phone | 18006214041 |
| sales@tetramed.com | |
| Phone | 18006214041 |
| sales@tetramed.com | |
| Phone | 18006214041 |
| sales@tetramed.com | |
| Phone | 18006214041 |
| sales@tetramed.com | |
| Phone | 18006214041 |
| sales@tetramed.com | |
| Phone | 18006214041 |
| sales@tetramed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00614138101623 [Primary] |
| GS1 | 10614138101620 [Unit of Use] |
| FQM | Bandage, Elastic |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00614138101623]
Ethylene Oxide
[00614138101623]
Ethylene Oxide
[00614138101623]
Ethylene Oxide
[00614138101623]
Ethylene Oxide
[00614138101623]
Ethylene Oxide
[00614138101623]
Ethylene Oxide
[00614138101623]
Ethylene Oxide
[00614138101623]
Ethylene Oxide
[00614138101623]
Ethylene Oxide
[00614138101623]
Ethylene Oxide
[00614138101623]
Ethylene Oxide
[00614138101623]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-16 |
| Device Publish Date | 2022-08-08 |
| 00614138101630 | COMFO-TEX ELASTIC BANDAGE LATEX FREE, 6INX5YD |
| 00614138101609 | COMFO-TEX ELASTIC BANDAGE LATEX FREE, 4INX5YD |
| 00614138101579 | COMFO-TEX ELASTIC BANDAGE LATEX FREE, 3INX5YD |
| 00614138101555 | COMFO-TEX ELASTIC BANDAGE LATEX FREE, 2INX5YD |
| 00614138101623 | STERILE COMFO-TEX LATEX FREE ELASTIC BANDAGE, 6INX5YD |
| 00614138101593 | STERILE COMFO-TEX LATEX FREE ELASTIC BANDAGE, 4INX5YD |
| 00614138101562 | STERILE COMFO-TEX LATEX FREE ELASTIC BANDAGE, 3INX5YD |
| 00614138101548 | STERILE COMFO-TEX LATEX FREE ELASTIC BANDAGE, 2INX5YD |