| Primary Device ID | 17540196000632 |
| NIH Device Record Key | 17a55b9d-07f2-4e3d-8ab3-09df3c48505d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENSURE Biological Indicators |
| Version Model Number | SCI-BI100 |
| Catalog Number | SCI-BI100 |
| Company DUNS | 204137145 |
| Company Name | Scican Ltd |
| Device Count | 100 |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 18006677733 |
| tboyce@scican.com | |
| Phone | 18006677733 |
| tboyce@scican.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540196000635 [Unit of Use] |
| GS1 | 17540196000632 [Primary] |
| FRC | Indicator, Biological Sterilization Process |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-02 |
| 27540196000639 | Self-contained biological indicators for steam sterilization containing bacterial endospores of |
| 17540196000632 | Self-contained biological indicators for steam sterilization containing bacterial endospores of |