SEALSURE™
GUDID 07798375772860
SEALSURE™ VH2O2 Indicator Tape 20mm
TERRAGENE S.A.
Chemical/physical sterilization process indicator| Primary Device ID | 07798375772860 |
| NIH Device Record Key | 9aa97b0c-86dd-4dab-a95f-f3999c18cb9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SEALSURE™ |
| Version Model Number | 73270 |
| 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 |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07798375772853 [Primary] |
| GS1 | 07798375772860 [Package] Contains: 07798375772853 Package: Case [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K232103
FDA Product Code
| JOJ | Indicator, Physical/Chemical Sterilization Process |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-12-08 |
| Device Publish Date | 2025-06-03 |
On-Brand Devices [SEALSURE™]
| 07798375772242 | SEALSURE™ Steam Indicator Tape 18mm |
| 07798375772860 | SEALSURE™ VH2O2 Indicator Tape 20mm |
Trademark Results [SEALSURE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SEALSURE 75934729 2810943 Live/Registered |
JOHNSON & JOHNSON 2000-03-03 |
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