| Primary Device ID | 10850200006619 |
| NIH Device Record Key | 7a188ea2-8268-4a12-bcd2-2154a126d981 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | C1® Device |
| Version Model Number | 022600 |
| Catalog Number | 022600 |
| Company DUNS | 603420183 |
| Company Name | LSI Solutions, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| 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 | true |
| Manufacturing Date | true |
| 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 |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850200006612 [Primary] |
| GS1 | 10850200006619 [Package] Contains: 00850200006612 Package: Case [6 Units] In Commercial Distribution |
| HCF | INSTRUMENT, LIGATURE PASSING AND KNOT TYING |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-30 |
| Device Publish Date | 2020-03-13 |
| 10850200006497 - SEW-EASY® | 2024-10-29 SEW-EASY® COMBO KIT, 5mm |
| 10850200006503 - SEW-EASY® | 2024-10-29 SEW-EASY® COMBO KIT, 3.5mm |
| 10850200006510 - SEW-EASY® | 2024-10-29 SEW-EASY® DEVICE KIT, 5mm |
| 10850200006527 - SEW-EASY® | 2024-10-29 SEW-EASY® DEVICE KIT, 3.5mm |
| 00850012846253 - multiSTATION™ | 2024-10-07 DOC-X 15™ EXTENDER |
| 00850012846352 - multiSTATION™ | 2024-10-07 DOC-X 25™ EXTENDER |
| 00850012846369 - multiSTATION™ | 2024-10-07 DOC-X 45™ EXTENDER |
| 10850012846045 - Mi-CHORD™ | 2024-07-22 Mi-CHORD™ SYSTEM |