| Primary Device ID | 07798375772242 |
| NIH Device Record Key | 62c0ef6e-1875-4bfb-ab35-db34ffb53cf5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SEALSURE™ |
| Version Model Number | 73170 |
| Company DUNS | 970856911 |
| Company Name | TERRAGENE S.A. |
| Device Count | 1 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com | |
| Phone | +1(888)783-7723 |
| ASP-Complaints@asp.com |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07798375772242 [Package] Contains: 07798375772303 Package: Case [4 Units] In Commercial Distribution |
| GS1 | 07798375772303 [Primary] |
| JOJ | Indicator, Physical/Chemical Sterilization Process |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-11-21 |
| Device Publish Date | 2023-11-13 |
| 07798164677291 - Bionova® | 2025-08-14 Self-contained Biological Indicator for monitoring steam sterilization processes |
| 07798164678045 - Bionova® | 2025-08-14 Self-contained Biological Indicator for monitoring steam sterilization processes |
| 07798164677970 - Bionova® | 2025-08-11 Test pack for steam sterilization processes |
| 07798164678052 - Bionova® | 2025-08-11 Auto-reader Incubator for biological indicators |
| 07798164678069 - Bionova® | 2025-08-11 Test pack for steam sterilization processes |
| 07798164678083 - Bionova® | 2025-08-11 Steam Test Pack PCD Kit (25 test packs and 25 control BIs) |
| 07798164678090 - Bionova® | 2025-08-11 Steam Test Pack PCD Kit (25 test packs and 25 control BIs) |
| 07798164674948 - Bionova® | 2025-05-05 Self-contained Biological Indicator for monitoring ethylene oxide sterilization processes with a minimum viable population of 10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SEALSURE 75934729 2810943 Live/Registered |
JOHNSON & JOHNSON 2000-03-03 |