| Primary Device ID | 10841736110826 |
| NIH Device Record Key | 310340ca-7157-4677-a75a-5d5ae8f81816 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Skytron Surg-Enz Multi-Enzymatic Cleaner |
| Version Model Number | J5-010-42 |
| Catalog Number | J5-010-42 |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841736110826 [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 | 2017-08-03 |
| 10841736124328 - Skytron | 2025-05-20 Shelf 39" for vertical column, Freedom |
| 10841736124304 - F101 SERIES MOUNT WITH 1 LF ARM | 2025-05-19 F101 SERIES MOUNT WITH 1 LF ARM |
| 10841736124311 - F102 SERIES MOUNT WITH 2 LF ARMS | 2025-05-19 F102 SERIES MOUNT WITH 2 LF ARMS |
| 10841736114985 - Skytron DoVera Positioning Handle | 2024-09-11 Skytron DoVera Positioning Handle (Camera Cover Handle) |
| 10841736124151 - Center Focus Handle | 2024-06-20 Center Focus Handle with Intensity Control for Lumos Series, black |
| 10841736124168 - Camera Cover | 2024-06-20 Sterilizable Camera Cover with intensity control for Lumos Series, black |
| 10841736123406 - Sterling M1000 | 2024-04-10 M1000 S208E, Single door, Electric, 208V |
| 10841736123413 - Sterling M1000 | 2024-04-10 M1000 S480E, Single door, Electric, 480V |