| Primary Device ID | 20653405008276 |
| NIH Device Record Key | 26419b80-e878-45ff-bcaa-23403cb3ba97 |
| Commercial Distribution Discontinuation | 2022-06-06 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | HAND-TROL GOLD LINE |
| Version Model Number | 60-0300-515 |
| Catalog Number | 60-0300-515 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 50 |
| 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 | 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 | 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 |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Temperature | Between -34 Degrees Celsius and 65 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Fahrenheit and 149 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653405008272 [Unit of Use] |
| GS1 | 10653405008279 [Primary] |
| GS1 | 20653405008276 [Package] Contains: 10653405008279 Package: BOX [50 Units] Discontinued: 2022-06-06 Not in Commercial Distribution |
| DWG | ELECTROSURGICAL DEVICE |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20653405008276]
Radiation Sterilization
[20653405008276]
Radiation Sterilization
[20653405008276]
Radiation Sterilization
[20653405008276]
Radiation Sterilization
[20653405008276]
Radiation Sterilization
[20653405008276]
Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-06-07 |
| Device Publish Date | 2016-09-24 |
| 20653405008269 | HAND-TROL GOLD LINE, ELECTROSURGICAL HANDPIECE |
| 10653405008255 | HAND-TROL GOLD LINE, ELECTROSURGICAL HANDPIECE |
| 20653405008276 | HAND-TROL GOLD LINE, ELECTROSURGICAL HANDPIECE |