Catalog Number

08-31-30031P

Brand Name

Medt

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

d45ba371-d1e6-4ae4-a060-b944c334e2a7

Public Version Date

September 12, 2018

Public Version Number

3

DI Record Publish Date

April 27, 2017

Package DI Number

M992083130031P3

Quantity per Package

10

Contains DI Package

M992083130031P1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box