Catalog Number

-

Brand Name

DUPLOSPRAY

Version/Model Number

0600030

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 20, 2021

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

K061092,K061092,K061092

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

5e7207dc-da10-478c-9e08-7a65127bb19c

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

January 13, 2017

Package DI Number

20815634020485

Quantity per Package

1

Contains DI Package

10815634020488

Package Discontinue Date

December 20, 2021

Package Status

Not in Commercial Distribution

Package Type

SHIP BOX