| Primary Device ID | 00361554002101 |
| NIH Device Record Key | e3e2bd51-22d3-484b-94ac-d8afacc9b1f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gentell FixTape (2x11 yards) |
| Version Model Number | GEN-10600 |
| Catalog Number | GEN-10600 |
| Company DUNS | 170967876 |
| Company Name | Gentell, LLC |
| Device Count | 64 |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00361554002101 [Unit of Use] |
| GS1 | 00361554002118 [Primary] |
| KGX | Tape And Bandage, Adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-03 |
| Device Publish Date | 2025-03-26 |
| 00361554002002 - Comfortell Composite Dressing (4x4 in | 2025-04-04 |
| 00361554002033 - Comfortell Composite Dressing (6x6 in) | 2025-04-04 |
| 00361554002903 - Calcium Alginate Dressing Rope (12 in) | 2025-04-04 |
| 00361554001678 - Dermatell Hydrocolloid (Non-Bordered) Wound Dressing (4x4 in) | 2025-04-03 |
| 00361554001708 - Dermatell Hydrocolloid (Bordered) Wound Dressing (4x4 in) | 2025-04-03 |
| 10361554001729 - Dermatell Hydrocolloid (Bordered) Wound Dressing (6x6 in) | 2025-04-03 |
| 00361554002101 - Gentell FixTape (2x11 yards) | 2025-04-03 |
| 00361554002101 - Gentell FixTape (2x11 yards) | 2025-04-03 |
| 00361554002125 - Gentell FixTape (4x11 yards) | 2025-04-03 |