Catalog Number

10BB

Brand Name

ENDOPATH

Version/Model Number

10BB

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

aede00b5-b2e5-4df6-aef1-39dd758b8e34

Public Version Date

November 12, 2021

Public Version Number

4

DI Record Publish Date

July 15, 2016

Package DI Number

30705036000376

Quantity per Package

36

Contains DI Package

10705036000372

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE