Catalog Number

RAN-8-301

Brand Name

RAN-8-301

Version/Model Number

8GA X 11CM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131157,K131157,K131157

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

87eb6485-f059-4647-b952-0865fcd1fcfd

Public Version Date

April 26, 2019

Public Version Number

1

DI Record Publish Date

April 18, 2019

Package DI Number

10857878007757

Quantity per Package

1

Contains DI Package

00857878007750

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner pack