Catalog Number

60727

Brand Name

AVANOS

Version/Model Number

92768

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

K941464,K941464

Product Code

PTS

Product Code Name

Endoscopic grasping/cutting instrument, non-powered, exempt

Public Device Record Key

978ec0a3-801a-44a3-923b-761226bc57e8

Public Version Date

September 18, 2019

Public Version Number

1

DI Record Publish Date

September 10, 2019

Package DI Number

10350770927685

Quantity per Package

5

Contains DI Package

00350770927688

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

EA