| Primary Device ID | 10845854902158 |
| NIH Device Record Key | 67ee9891-f8de-4f51-809a-746792460ac9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Y-Knot, OneStep |
| Version Model Number | Y1SG1 |
| Catalog Number | Y1SG1 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| Expiration Date | false |
| 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)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM | |
| Phone | +1(800)237-0169 |
| CUSTOMER_SERVICE@CONMED.COM |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10845854902158 [Primary] |
| FZX | Guide, surgical, instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10845854902158]
Moist Heat or Steam Sterilization
[10845854902158]
Moist Heat or Steam Sterilization
[10845854902158]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2020-04-28 |
| 20845854902117 | Y-Knot® OneStep™ Anchor, Two Ribbons |
| 20845854902100 | Y-Knot® OneStep™ Anchor, One Ribbon (Black) |
| 20845854902094 | Y-Knot® OneStep™ Anchor, One Ribbon (Blue) |
| 20845854901851 | Y-Knot® OneStep™ Anchor, Two #2 Hi-Fi |
| 20845854901844 | Y-Knot® OneStep™ Anchor, One #2 Hi-Fi (Black) |
| 10845854902189 | Y-Knot® OneStep™ Obturator, Straight, Reusable |
| 20845854901837 | Y-Knot OneStep Anchor, One No. 2 Hi-Fi (Blue) |
| 10845854902172 | Y-Knot® OneStep™ Guide, Crown |
| 10845854902165 | Y-Knot OneStep Guide, Crown Curved |
| 10845854902158 | Y-Knot OneStep Guide, Fishmouth |
| 30845854648661 | Y-Knot OneStep Guide, Crown |
| 30845854648647 | Y-Knot OneStep Guide, Fishmouth |
| 20845854083458 | Y-Knot® OneStep™ Anchor, Two #2 Hi-Fi |
| 20845854083441 | Y-Knot® OneStep™ Anchor, One #2 Hi-Fi (Black) |
| 20845854083434 | Y-Knot OneStep Anchor, One No. 2 Hi-Fi (Blue) |