Catalog Number

NG037R

Brand Name

PLASMACUP

Version/Model Number

NG037R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 25, 2022

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

-

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

7638be21-65d8-4ee4-be87-7e1749c13051

Public Version Date

May 03, 2022

Public Version Number

3

DI Record Publish Date

May 08, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-