Catalog Number

PNM-6ENSTB

Brand Name

NEOMED*

Version/Model Number

PNM-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)

-

Over the Counter (OTC)

Yes

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

b1c9151d-a025-4c9b-b309-b5a9d1da3df6

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 2021

Package DI Number

10350770001903

Quantity per Package

50

Contains DI Package

00350770001906

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

DSP