Catalog Number

-

Brand Name

MEDEM

Version/Model Number

MD16050-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K172344,K172344

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

69e5bfb0-bcc7-4c2a-8b6e-d05bea0da322

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 10, 2018

Package DI Number

18056772676515

Quantity per Package

10

Contains DI Package

08056772676518

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-