Catalog Number

-

Brand Name

NA

Version/Model Number

AG-5099-05

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

K201121,K201121,K201121

Product Code

KNS

Product Code Name

Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Public Device Record Key

6adcfceb-7d0e-4baf-bb7d-d2a09c603c82

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 09, 2022

Package DI Number

16959664912123

Quantity per Package

10

Contains DI Package

06959664912126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box