Adherent Bag - For the adherent cell culture inside the SCINUS - Scinus Cell Expansion Netherlands B.V.

Duns Number:493047487

Device Description: For the adherent cell culture inside the SCINUS the Adherent Bag is used. ThisAdherent Bag

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More Product Details

Catalog Number

-

Brand Name

Adherent Bag

Version/Model Number

ADH-01-01

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

KJF

Product Code Name

System, Suspension, Cell Culture

Device Record Status

Public Device Record Key

06c8caaf-7233-48a2-8105-3f13f5467f17

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

December 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCINUS CELL EXPANSION NETHERLANDS B.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5