Catalog Number

60811

Brand Name

AVANOS

Version/Model Number

92770

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

FBK

Product Code Name

endoscopic injection needle, gastroenterology-urology

Public Device Record Key

4c7e6598-c959-48ff-af01-383b7d0b8880

Public Version Date

August 05, 2019

Public Version Number

1

DI Record Publish Date

July 27, 2019

Package DI Number

10350770927708

Quantity per Package

10

Contains DI Package

00350770927701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EA