STERILE CBS 0.5 ML STRAW FOR SPERM WITH COTTON PLUG / 5 x 20 - CRYO BIO SYSTEM

Duns Number:500731872

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More Product Details

Catalog Number

014650

Brand Name

STERILE CBS 0.5 ML STRAW FOR SPERM WITH COTTON PLUG / 5 x 20

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

K002595

Product Code Details

Product Code

MQG

Product Code Name

Accessory, Assisted Reproduction

Device Record Status

Public Device Record Key

5c69a947-2a5e-4ea0-9607-9ade92284abf

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