Catalog Number

-

Brand Name

Integra®

Version/Model Number

3805415

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 04, 2019

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

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

c29cc943-7cc3-4de9-9d54-c35f3e9abef6

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 08, 2019

Package DI Number

30381780511315

Quantity per Package

10

Contains DI Package

10381780511311

Package Discontinue Date

March 04, 2019

Package Status

Not in Commercial Distribution

Package Type

Case