Catalog Number

69392

Brand Name

Halyard

Version/Model Number

92810

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)

Yes

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

K841258,K841258,K841258

Product Code

FED

Product Code Name

endoscopic access overtube, gastroenterology-urology

Public Device Record Key

8fa55aa5-9c2f-4fa9-a714-a98e059021b9

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

September 15, 2016

Package DI Number

30609038024531

Quantity per Package

10

Contains DI Package

10680651928105

Package Discontinue Date

April 12, 2017

Package Status

Not in Commercial Distribution

Package Type

CS