| Primary Device ID | 20653405012198 |
| NIH Device Record Key | 4de9ac96-aa0a-464a-aeac-3f9b71213741 |
| Commercial Distribution Discontinuation | 2020-12-08 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | SELECT ONE |
| Version Model Number | 60-6050-894 |
| Catalog Number | 60-6050-894 |
| Company DUNS | 071595540 |
| Company Name | Conmed Corporation |
| Device Count | 4 |
| 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 | |
| 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 |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Temperature | Between -20 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Handling Environment Temperature | Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 16 Degrees Celsius and 27 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 90 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between -29 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00653405012194 [Unit of Use] |
| GS1 | 10653405012191 [Primary] |
| GS1 | 20653405012198 [Package] Contains: 10653405012191 Package: BOX [4 Units] Discontinued: 2020-12-08 Not in Commercial Distribution |
| KOD | CATHETER, UROLOGICAL |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
[20653405012198]
Ethylene Oxide;Radiation Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-12-08 |
| Device Publish Date | 2016-09-24 |
| 20653405033773 | SELECT ONE LAPAROSCOPIC PROCEDURE PACK |
| 10653405040798 | SELECT ONE LAPAROSCOPIC PROCEDURE PACK |
| 20653405012198 | SELECT ONE LAPAROSCOPIC PROCEDURE PACK |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SELECT ONE 97003974 not registered Live/Pending |
SelectMark, Inc. 2021-08-31 |
![]() SELECT ONE 85606825 4511347 Live/Registered |
Cancer Genetics, Inc. 2012-04-24 |
![]() SELECT ONE 78228832 not registered Dead/Abandoned |
BUYMOR CORPORATION 2003-03-22 |
![]() SELECT ONE 78228830 not registered Dead/Abandoned |
BUYMOR CORPORATION 2003-03-22 |
![]() SELECT ONE 76375803 not registered Dead/Abandoned |
Select Distributors, Inc. 2002-02-21 |
![]() SELECT ONE 75509535 2352656 Dead/Cancelled |
LEINER HEALTH SERVICES CORP. 1998-06-17 |
![]() SELECT ONE 74720897 2134824 Dead/Cancelled |
Business Computing Partners, Inc. 1995-08-15 |
![]() SELECT ONE 74477802 1865708 Dead/Cancelled |
CONMED CORPORATION 1994-01-10 |