| Primary Device ID | 10814434020346 |
| NIH Device Record Key | 10567f9a-7822-4812-bf9f-fbfb91a1e89a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Getinge Sterilization Indicator Tape 1" |
| Version Model Number | 61301600034 |
| Catalog Number | 61301600034 |
| Company DUNS | 622223196 |
| Company Name | STERITEC PRODUCT MFG. CO., INC. |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 10 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 38 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 38 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814434020349 [Primary] |
| GS1 | 10814434020346 [Package] Contains: 00814434020349 Package: Case [36 Units] In Commercial Distribution |
| JOJ | Indicator, Physical/Chemical Sterilization Process |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-22 |
| Device Publish Date | 2016-09-23 |