Catalog Number

-

Brand Name

NA

Version/Model Number

AG-5075-241523

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

25e49ffd-c8a2-4c54-9aff-5861e0781dd6

Public Version Date

May 01, 2019

Public Version Number

1

DI Record Publish Date

April 23, 2019

Package DI Number

66959664910940

Quantity per Package

10

Contains DI Package

56959664910943

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-