Catalog Number

-

Brand Name

NA

Version/Model Number

AG-5078-242523

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

K172729,K172729,K172729

Product Code

FDI

Product Code Name

Snare, Flexible

Public Device Record Key

cc8cb127-4afb-425e-86c9-5265d32f8373

Public Version Date

October 18, 2022

Public Version Number

1

DI Record Publish Date

October 10, 2022

Package DI Number

16959664911843

Quantity per Package

10

Contains DI Package

06959664911846

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box