u-test Self-Contained Biological Indicator for Steam Sterilization (SCBI)

GUDID 00060705811547

MAXILL, INC.

Biological sterilization indicator
Primary Device ID00060705811547
NIH Device Record Keyded47276-892f-4184-ab4d-732a89a4ef59
Commercial Distribution StatusIn Commercial Distribution
Brand Nameu-test Self-Contained Biological Indicator for Steam Sterilization (SCBI)
Version Model Number81154
Company DUNS079343581
Company NameMAXILL, INC.
Device Count50
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-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100060705811547 [Primary]
GS190060705811540 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

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 Number3
Public Version Date2018-07-06
Device Publish Date2017-08-17

Devices Manufactured by MAXILL, INC.

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