| Primary Device ID | 10843356100713 |
| NIH Device Record Key | 08d93809-1f3e-40ca-b19e-0a86f0a4e305 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gemini Twin Cleaning Pads with enzymatic detergent |
| Version Model Number | GP120Z |
| Company DUNS | 103169095 |
| Company Name | CYGNUS MEDICAL L.L.C. |
| Device Count | 2 |
| 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 | 00843356100716 [Primary] |
| GS1 | 10843356100713 [Package] Contains: 00843356100716 Package: [120 Units] In Commercial Distribution |
| GS1 | 30843356100717 [Unit of Use] |
| MNL | Accessories, Cleaning Brushes, For Endoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-02 |
| Device Publish Date | 2020-09-24 |
| 00843356102963 - CYGNUS | 2026-01-23 ERCP160 SET WITH ONE EACH OF: ASOA3, ASOA5, ASOA6, THREADED CONNECTOR, AND 2.5" SOFT TUBING 100 PER CASE |
| 00843356102888 - CYGNUS | 2025-12-24 ERCP190 SET WITH ONE EACH OF: ASOA3 ASOA5 ASOA6 2.5" SOFT TUBING 100 PER CASE |
| 00843356102895 - CYGNUS | 2025-12-24 EUS Raidial160 SET WITH ONE EACH OF: ASOA3 ASOA9 ASOA6 2.5" SOFT TUBE 100 PER CASE |
| 00843356102857 - CYGNUS | 2025-07-21 CLEAN CHEMO DUAL LAYER LABEL 500 PER CASE |
| 00843356102864 - CYGNUS | 2025-07-21 Slip Connector 500 per case |
| 00843356101812 - Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12 | 2025-01-08 Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12/31/2024. No R Version on Gator Clips - All cli |
| 00843356101829 - Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12 | 2025-01-08 Use Assigned GITN before 12/31/2024. Currently unpublished. Will publish on 12/31/2024. No R version on Gator Clips - All cli |
| 10843356102694 - CYGNUS | 2024-12-19 Tip Gard 500 Per Bag, 2000 Per Case |