FDA.reportPublic FDA data

STERLINK™

Primary DI
08800066500221
Brand
STERLINK™
Company
Plasmapp Co.,Ltd.
Model
Mini-bio
Device description
Terragene® Bionova© Reader Incubators (Mini-Bio) incubate at 60 °C and 37 °C and read the Terragene® Bionova© SCBI for fluorescent results at the times prescribed in the User Manuals.
Published
2021-12-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FRCIndicator, Biological Sterilization Process
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212193000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212193000Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)Plasmapp Co,., Ltd.2021-10-22FRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800066500221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800066500221088000665002218800066500221

GMDN Terms#

Term, Definition table
TermDefinition
Biological sterilization indicator readerA mains electricity (AC-powered) device designed to accept a biological sterilization indicator (bacterial spores) and to rapidly indicate whether adequate sterilization conditions have been achieved by testing the resistance of the biological indicator previously exposed to a sterilization process (e.g., by steam, or chemical sterilization). It is a bench-top unit intended to provide suitable incubation conditions for the biological indicator and to detect fluorescent enzymatic signals that correlate with the resistance of the biological indicator.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695798956
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800066500306STERILINK™110V2023-07-13
08800066500191STERLINK™CD422021-11-26
08800066500207STERLINK™CT402021-11-26
08800066500313STERILINK™110V2023-07-13
08800066500030STERLINK™STERLOAD2021-11-26
08800066500054STERLINK™FPS-15s Plus2021-11-26
08800066500320STERILINK™110V2023-07-13
08800066500269ACTILINK™ACTILINK reborn2023-02-24
08800066500245ACTILINK™ACTILINK mini2022-03-04
08800066500184STERLINK™BT962021-11-26
08800066500214STERLINK™FR4001002021-11-26

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Primary DI, Brand, Company table
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