| Primary Device ID | 30845854061927 |
| NIH Device Record Key | 0ce513b3-3bef-44d0-b3bc-12b1f960ef20 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 57525332 |
| Catalog Number | 57525332 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 10 |
| DM Exempt | false |
| 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 | 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 | 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *KEEP DRY |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 0.5 KiloPascal and 1.06 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00845854061926 [Unit of Use] |
| GS1 | 20845854061920 [Primary] |
| GS1 | 30845854061927 [Package] Contains: 20845854061920 Package: Box [10 Units] In Commercial Distribution |
| FYD | APPARATUS, EXHAUST, SURGICAL |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
[30845854061927]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-10 |
| Device Publish Date | 2020-07-31 |
| 30845854026797 - GENESYS CrossFT, Hi-Fi | 2024-04-25 5.5 mm GENESYS CrossFT Suture Anchor with Three #2 (5 metric) Hi-Fi Sutures |
| 30845854026803 - GENESYS CrossFT, Hi-Fi | 2024-04-25 6.5 mm GENESYS CrossFT Suture Anchor with Two #2 (5 metric) Hi-Fi Sutures |
| 30845854026810 - GENESYS CrossFT, Hi-Fi | 2024-04-25 6.5 mm GENESYS CrossFT Suture Anchor with Three #2 (5 metric) Hi-Fi Sutures |
| 30845854027862 - GENESYS PressFT, Hi-Fi | 2024-04-25 GENESYS PressFT 2.1 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black) |
| 30845854027893 - GENESYS PressFT, Hi-Fi | 2024-04-25 GENESYS PressFT 2.6 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black) |
| 30845854034600 - GENESYS CrossFT, Hi-Fi | 2024-04-25 GENESYS CrossFT 5.5 mm Suture Anchor, w/3 Hi-Fi #2 (5 metric) Sutures w/Needles |
| 30845854034617 - GENESYS CrossFT, Hi-Fi | 2024-04-25 GENESYS CrossFT 6.5 mm Suture Anchor, w/2 Hi-Fi #2 (5 metric) Sutures w/Needles |
| 30653405988643 - Argo Knotless GENESYS | 2024-04-22 5.5mm Argo Knotless® GENESYSTM Anchor |