Catalog Number

X41761TT

Brand Name

Integra® Jarit®

Version/Model Number

X41761TT

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

-

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

HHM

Product Code Name

SOUND, UTERINE

Public Device Record Key

7e17939e-8bce-45ee-8dfd-1fef1b9d3678

Public Version Date

June 23, 2021

Public Version Number

4

DI Record Publish Date

May 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-