Catalog Number

-

Brand Name

SheathesGel

Version/Model Number

60001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130041,K130041,K130041,K130041

Product Code

MUI

Product Code Name

Media,Coupling,Ultrasound

Public Device Record Key

cf9eb550-9648-4ef3-9a06-b24661027824

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

August 22, 2017

Package DI Number

20842418102129

Quantity per Package

3

Contains DI Package

10842418102122

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE