Catalog Number

RTN-114-T

Brand Name

RTN-114-T, F/G

Version/Model Number

11GA X 4

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

K983187,K983187,K983187

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

82917765-e711-4928-9ed3-a2865cd475c2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 12, 2017

Package DI Number

20857878007167

Quantity per Package

12

Contains DI Package

10857878007160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-