STERLINK™ - Cintape® CT40 Process Indicators (Type 1 - Plasmapp Co.,Ltd.

Duns Number:695798956

Device Description: Cintape® CT40 Process Indicators (Type 1 according ISO 11140-1:2014 standard) are single-u

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More Product Details

Catalog Number

-

Brand Name

STERLINK™

Version/Model Number

CT40

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K212193

Product Code Details

Product Code

FRC

Product Code Name

Indicator, Biological Sterilization Process

Device Record Status

Public Device Record Key

bac092d4-f5a2-4ef7-b7ef-149f6622c5e1

Public Version Date

December 06, 2021

Public Version Number

1

DI Record Publish Date

November 26, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PLASMAPP CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 7