Regenerative medicine-Single-use kits - Biosafe S.A.

Duns Number:488052341

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More Product Details

Catalog Number

10006

Brand Name

Regenerative medicine-Single-use kits

Version/Model Number

CS-600.1

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

JQC

Product Code Name

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Device Record Status

Public Device Record Key

d4f56fce-9e6d-45c7-9b10-17ad6fc473df

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

January 13, 2017

Additional Identifiers

Package DI Number

07640125650297

Quantity per Package

6

Contains DI Package

07640125650280

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOSAFE S.A." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 24