Catalog Number

PNM-S100EOV

Brand Name

GravityPro

Version/Model Number

PNM-S100EOV

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

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

fa19e8d1-bf0c-4b06-b6e4-25d27d59fced

Public Version Date

October 29, 2021

Public Version Number

6

DI Record Publish Date

September 19, 2016

Package DI Number

10817584011202

Quantity per Package

40

Contains DI Package

00817584011205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case