Catalog Number

DYNJTS011

Brand Name

MEDLINE

Version/Model Number

DYNJTS011

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

-

Product Code

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

7ff98beb-ceb1-42ca-b528-fe854293a8f1

Public Version Date

May 26, 2020

Public Version Number

1

DI Record Publish Date

May 18, 2020

Package DI Number

40889942602293

Quantity per Package

10

Contains DI Package

10889942602292

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE