Catalog Number

-

Brand Name

EndoGlide+™

Version/Model Number

M00501903

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

-

Product Code

KMJ

Product Code Name

Lubricant, Patient

Public Device Record Key

78f85fd0-da70-46de-9df2-7b8bb251426d

Public Version Date

October 03, 2022

Public Version Number

3

DI Record Publish Date

April 15, 2022

Package DI Number

16921865500027

Quantity per Package

20

Contains DI Package

06921865500105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-