Catalog Number

NM-6ENSTB

Brand Name

NEOMED*

Version/Model Number

NM-6ENSTB

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

ILC

Product Code Name

UTENSIL, EATING

Public Device Record Key

97d8c59a-7933-42c0-aa05-bf0ddeaaffd4

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 2021

Package DI Number

20350770001894

Quantity per Package

8

Contains DI Package

10350770001897

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS