Catalog Number

3805428

Brand Name

Integra®

Version/Model Number

3805428

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

K960248,K960248,K960248

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

8581f2c4-1c4a-4288-a830-9b9c924f4b5f

Public Version Date

March 13, 2019

Public Version Number

1

DI Record Publish Date

March 05, 2019

Package DI Number

30381780527002

Quantity per Package

10

Contains DI Package

10381780527008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case