| Primary Device ID | 04260463840964 |
| NIH Device Record Key | 7b69d0c4-7587-40c8-8157-dc270925c79c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STERILE COVER PU /10 EA. |
| Version Model Number | 110096 |
| Company DUNS | 537223815 |
| Company Name | Aktormed GmbH |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260463840964 [Primary] |
| KKX | Drape, Surgical |
| PUI | Drape, Surgical, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-20 |
| Device Publish Date | 2022-04-12 |
| 04260463842333 - ENDOSCOPE CLAMP A | 2026-03-05 Standard endoscope clamp with a clamping range from Ø7 to Ø20mm, suitable to the quick lock of the ENDOFIX exo |
| 04260463845273 - STERILISATION TRAY | 2026-03-05 Sterilisation tray with small parts tray for sterilisable parts of ENDOFIX exo |
| 04260463846867 - ENDOSCOPE CLAMP B | 2026-03-05 suitable to the quick lock of the ENDOFIX exo in combination with tension sleeve D10 or Cone Adapter 1412-61404. Clamping range |
| 04260463849066 - CONTROL | 2026-03-05 for ENDOFIX exo, autoclavable |
| 04260463849127 - ENDOFIX EXO SET | 2026-03-05 with quick fastener to OR table Supply: 100 - 240 V, 50 - 60 Hz, 2,5 A consisting of: 1x arm system for endoscopes/exoscopes wit |
| 04260463849271 - CONE ADAPTER | 2026-03-05 for optics |
| 04260463849431 - Endofix EXO | 2025-08-07 |
| 04260463845181 - PROBE PIN | 2024-10-10 autoclavable accessories for the DEXTER ENDOSCOPE ARM |