Primary Device ID | 27540196000639 |
NIH Device Record Key | 1f917fe2-1d4f-49da-9db4-94d9559a6410 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ENSURE Biological Indicators |
Version Model Number | SCI-BI25 |
Catalog Number | SCI-BI25 |
Company DUNS | 204137145 |
Company Name | Scican Ltd |
Device Count | 25 |
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 | 27540196000639 [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 |