Catalog Number

-

Brand Name

NA

Version/Model Number

AG-55344-2300-090-16S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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"

Yes

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

K172727,K172727,K172727,K172727,K172727,K172727,K172727

Product Code

PKL

Product Code Name

Hemostatic Metal Clip For The Gi Tract

Public Device Record Key

d775488e-a83b-485f-818a-cdb4a58ce97f

Public Version Date

August 06, 2018

Public Version Number

1

DI Record Publish Date

July 05, 2018

Package DI Number

66959664911220

Quantity per Package

10

Contains DI Package

56959664911223

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-