| Primary Device ID | 10841736110499 |
| NIH Device Record Key | 2b2e0dd3-c055-4ebe-8d75-f57bff28d2b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Skytron Enzymatic cleaner |
| Version Model Number | J5-010-02 |
| Catalog Number | J5-010-02 |
| Company DUNS | 078375583 |
| Company Name | SKYTRON LLC |
| 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 | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us | |
| Phone | +1(800)759-8766 |
| info@skytron.us |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841736110499 [Primary] |
| MEC | Disinfector, medical devices |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2023-10-04 |
| Device Publish Date | 2016-12-21 |
| 10841736124298 - Skytron LLC | 2025-12-17 Active Assist Hold/Manual Control Assy Mounted on 3" LD VST, Freedom |
| 10841736124427 - Sterling | 2025-12-17 P/M1000 MIS Rack with accessories |
| 10841736124434 - Sterling | 2025-12-17 P1800 MIS Rack with accessories |
| 10841736124861 - Skytron | 2025-12-11 8 inch Clamp for P.T.E. (2 Pack) |
| 10841736124878 - Skytron | 2025-12-11 2 inch STERIS 548 ARMBOARD PAD WS |
| 10841736124885 - Skytron | 2025-12-11 3 inch STERIS 548 ARMBOARD PAD WS |
| 10841736124892 - Skytron | 2025-12-11 4 inch STERIS 548 ARMBOARD PAD WS |
| 10841736124908 - Skytron | 2025-12-11 5 inch STERIS 548 ARMBOARD PAD WS |