Catalog Number

-

Brand Name

Duplotip

Version/Model Number

0601136

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"

-

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

K033589,K033589,K033589

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

e29f057d-3f4a-4446-8b6b-3f00f0922829

Public Version Date

July 16, 2018

Public Version Number

1

DI Record Publish Date

June 15, 2018

Package DI Number

20815634020515

Quantity per Package

1

Contains DI Package

10815634020518

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Ship Box