ENSURE Biological Indicators SCI-BI25

GUDID 27540196000639

Self-contained biological indicators for steam sterilization containing bacterial endospores of G. stearothermophilus. 25-count.

Scican Ltd

Biological sterilization indicator Biological sterilization indicator
Primary Device ID27540196000639
NIH Device Record Key1f917fe2-1d4f-49da-9db4-94d9559a6410
Commercial Distribution StatusIn Commercial Distribution
Brand NameENSURE Biological Indicators
Version Model NumberSCI-BI25
Catalog NumberSCI-BI25
Company DUNS204137145
Company NameScican Ltd
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS107540196000635 [Unit of Use]
GS127540196000639 [Primary]

FDA Product Code

FRCIndicator, Biological Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-02

On-Brand Devices [ENSURE Biological Indicators]

27540196000639Self-contained biological indicators for steam sterilization containing bacterial endospores of
17540196000632Self-contained biological indicators for steam sterilization containing bacterial endospores of

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