Caplugs/Evergreen - PROCESS EMBEDD CASS W/COVER - CAPlugs

Duns Number:098203461

Device Description: PROCESS EMBEDD CASS W/COVER

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More Product Details

Catalog Number

258-4232-B90

Brand Name

Caplugs/Evergreen

Version/Model Number

258-4232-B90

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

KET

Product Code Name

FILTERS, CELL COLLECTION, TISSUE PROCESSING

Device Record Status

Public Device Record Key

59baf257-ff0c-41ee-b074-ce6f3bc4af23

Public Version Date

August 30, 2022

Public Version Number

2

DI Record Publish Date

December 31, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAPLUGS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 333