BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - GREEN - CRYO BIO SYSTEM

Duns Number:500731872

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More Product Details

Catalog Number

025251

Brand Name

BATCH OF 4 HSV HIGH SECURITY VITRIFICATION STRAWS - GREEN

Version/Model Number

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

-

Product Code Name

-

Device Record Status

Public Device Record Key

c04e0026-be63-4f63-96b2-38c251b7278f

Public Version Date

November 09, 2020

Public Version Number

1

DI Record Publish Date

October 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CRYO BIO SYSTEM" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 21