Catalog Number

ND-FS

Brand Name

NEOMED*

Version/Model Number

ND-FS

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"

-

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

FME

Product Code Name

Gown, examination

Public Device Record Key

f7894eb2-00e8-4fb4-96a7-884a2d1e4b0e

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

August 17, 2021

Package DI Number

10350770003372

Quantity per Package

40

Contains DI Package

00350770003375

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS