Catalog Number

-

Brand Name

Single Use Hemoclip

Version/Model Number

MD-A-HR-195-16-090-N

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"

-

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

K212669,K212669,K212669

Product Code

PKL

Product Code Name

Hemostatic Metal Clip For The Gi Tract

Public Device Record Key

f0aaffde-1e8a-494c-a6bb-9e63ae673df5

Public Version Date

August 25, 2022

Public Version Number

1

DI Record Publish Date

August 17, 2022

Package DI Number

16970401815316

Quantity per Package

10

Contains DI Package

06970401814602

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box