Catalog Number

RAN-11B

Brand Name

RAN-11B

Version/Model Number

11GA 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

47a67151-9a7f-4de7-95ec-6994adc14562

Public Version Date

January 17, 2022

Public Version Number

1

DI Record Publish Date

January 07, 2022

Package DI Number

10850023741599

Quantity per Package

10

Contains DI Package

00850023741592

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack