| Primary Device ID | 30845854061903 |
| NIH Device Record Key | 10dc96d4-7161-4d80-bcde-46c61b2c69a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 57525328 |
| Catalog Number | 57525328 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 24 |
| 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 | 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 | 00845854061902 [Unit of Use] |
| GS1 | 20845854061906 [Primary] |
| GS1 | 30845854061903 [Package] Contains: 20845854061906 Package: Box [24 Units] In Commercial Distribution |
| GAZ | TUBING, NONINVASIVE |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
Radiation Sterilization
[30845854061903]
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 |
| 20653405007194 - UltraClean | 2024-04-18 UltraClean Accessory Electrode 1" Coated Blade with Extended Insulation |
| 10845854026793 - GENESYS CROSSFT | 2024-04-18 5.5MM CROSSFT-BC ANCHOR, W/DISP, TRP |
| 10845854026809 - GENESYS CROSSFT | 2024-04-18 6.5MM CROSSFT-BC ANCHOR, W/DISP, DBL |
| 10845854026816 - GENESYS CROSSFT | 2024-04-18 6.5MM CROSSFT-BC ANCHOR, W/DISP, TRP |
| 10845854027868 - GENESYS PRESSFT | 2024-04-18 GENESYS PRESS FT 2.1 W/ONE # 2 (5 METRIC) HI-FI SUTURE, HIP |
| 10845854027899 - GENESYS PRESSFT | 2024-04-18 GENSESYS PRESSFT 2.6 W/ ONE # 2 (5 METRIC) HI-FI- SUTURE, HIP |
| 10845854034606 - GENESYS CROSSFT | 2024-04-18 GENESYS CROSSFT 5.5MM SUTURES ANCHOR, W/ 3 HI-FI #2 (5 METRIC) SUTURES W/NEEDLES |
| 10845854034613 - GENESYS CROSSFT | 2024-04-18 GENESYS CROSSFT 6.5MM SUTURE ANCHOR, W/ 2 HI-FI (5 METRIC) SUTURES W/NEEDLES |