Catalog Number

FNM-2205-UG

Brand Name

Medistar/Hatch (Private Label)

Version/Model Number

FNM-2205-UG

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 02, 2019

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"

-

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

K851831,K851831,K851831

Product Code

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

85e86619-ca76-4773-91bb-0539927f0161

Public Version Date

July 19, 2021

Public Version Number

4

DI Record Publish Date

October 14, 2016

Package DI Number

20859013006035

Quantity per Package

10

Contains DI Package

10859013006038

Package Discontinue Date

March 02, 2019

Package Status

Not in Commercial Distribution

Package Type

Unit Boxes