Catalog Number

RAN-825HRT

Brand Name

RAN-825HRT 514001-040

Version/Model Number

8GA x 250mm

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

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

312b0dd4-e72a-42db-9ac4-c49997d8e8c7

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 06, 2018

Package DI Number

10857878007184

Quantity per Package

100

Contains DI Package

00857878007187

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-