| Primary Device ID | 90843356102775 |
| NIH Device Record Key | 1f728b8f-8557-40af-a6b6-907018408800 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CYGNUS |
| Version Model Number | EC0612-SI |
| Company DUNS | 103169095 |
| Company Name | CYGNUS MEDICAL L.L.C. |
| Device Count | 100 |
| 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 | false |
| 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 | 00843356102772 [Primary] |
| GS1 | 90843356102775 [Unit of Use] |
| PXV | General Purpose Instrument Tray |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-28 |
| Device Publish Date | 2024-11-20 |
| 10843356102731 | 12"x18" Tray Liner 50 parts per bag |
| 10843356102724 | 12"x16" Tray Liner 50 parts per bag |
| 10843356102717 | 12"x12" Tray Liner 50 parts per bag |
| 10843356102687 | 23"x23" Tray Liner 50 parts per bag |
| 30843356102674 | 12"x23" Tray Liner 50 parts per bag. |
| 00843356102833 | SingleCycle Clean Self-Sealing label 25" 300 per case |
| 00843356102826 | SingleCycle Clean Self-Sealing label 20" 500 per case |
| 00843356102819 | SingleCycle Clean Self-Sealing label 15" 500 per case |
| 90843356102805 | Eight 100' rolls of Tray Belt Low Temperature |
| 00843356102840 | HIGH LEVEL DISINFECTED LABEL ROLL, 250 PER ROLL, 2 ROLLS PER CASE |
| 90843356102799 | Enhanced Coating Single Cycle, EC0713 with label 60 per case |
| 90843356102782 | Enhanced Coating Single Cycle, EC0713 60 per case |
| 90843356102775 | Enhanced Coating Single Cycle, EC0612 with label 100 per case |
| 90843356102768 | Enhanced Coating Single Cycle, EC0612 100 per case |
| 90843356102751 | Enhanced Coating Single Cycle, EC0308 with label 100 per case |
| 90843356102744 | Enhanced Coating Single Cycle, EC0308 100 per case |
| 10843356102694 | Tip Gard 500 Per Bag, 2000 Per Case |
| 00843356102864 | Slip Connector 500 per case |
| 00843356102857 | CLEAN CHEMO DUAL LAYER LABEL 500 PER CASE |