Catalog Number

08-01-30031P

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

8c666372-9187-4a10-98c4-2a237aa1dfdd

Public Version Date

September 12, 2018

Public Version Number

3

DI Record Publish Date

April 27, 2017

Package DI Number

M992080130031P5

Quantity per Package

5

Contains DI Package

M992080130031P3

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

corrugated case