| Primary Device ID | 05708932769426 |
| NIH Device Record Key | 4c6353ee-60ef-43b8-8a6e-4b406a538e75 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Biatain Fiber |
| Version Model Number | 33508 |
| Catalog Number | 33508 |
| Company DUNS | 305524696 |
| Company Name | Coloplast A/S |
| Device Count | 1 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com | |
| Phone | +1(800)533-0464 |
| healthcarecs@coloplast.com |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Width | 1 Inch |
| Length | 18 Inch |
| Length | 46 Centimeter |
| Width | 2.5 Centimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05708932769402 [Primary] |
| GS1 | 05708932769419 [Package] Contains: 05708932769402 Package: Retail Box [10 Units] In Commercial Distribution |
| GS1 | 05708932769426 [Package] Contains: 05708932769419 Package: Shipper Box [21 Units] In Commercial Distribution |
| NAC | Dressing, wound, hydrophilic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-20 |
| Device Publish Date | 2024-12-12 |
| 05708932769426 | 33508 |
| 05708932769396 | 33506 |
| 05708932769365 | 33504 |
| 05708932769334 | 33501 |