| Primary Device ID | 00849405002666 |
| NIH Device Record Key | aaf65f66-2036-4c37-af3e-189e3d55bc5f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XLR8 Transparent Film Dressing |
| Version Model Number | A4-S00F5-UNS |
| Catalog Number | A4-S00F5-UNS |
| Company DUNS | 006616130 |
| Company Name | GENADYNE BIOTECHNOLOGIES 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00849405002666 [Primary] |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00849405002666]
Ethylene Oxide
[00849405002666]
Ethylene Oxide
[00849405002666]
Ethylene Oxide
[00849405002666]
Ethylene Oxide
[00849405002666]
Ethylene Oxide
[00849405002666]
Ethylene Oxide
[00849405002666]
Ethylene Oxide
[00849405002666]
Ethylene Oxide
[00849405002666]
Ethylene Oxide
[00849405002666]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-11 |
| Device Publish Date | 2025-12-03 |
| 00849405000013 | Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm. |
| 00849405002666 | Unsterile Polyurethane film with medical grade acrylic adhesive, size 26 x 30 cm. |