Catalog Number

315000

Brand Name

BIG TAB®

Version/Model Number

315000

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

4d88b262-1d84-46b5-b515-52daa78b72ab

Public Version Date

March 03, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

04022495769466

Quantity per Package

2

Contains DI Package

04046964833311

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton