Catalog Number

-

Brand Name

Cooley Tangential Occlusion Clamp

Version/Model Number

2100-271

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"

Yes

For Single-Use

-

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

K092544

Product Code

DXC

Product Code Name

CLAMP, VASCULAR

Public Device Record Key

f62ad7f5-fe92-4e0f-8d6b-cd1c757fc0a8

Public Version Date

May 13, 2021

Public Version Number

1

DI Record Publish Date

May 05, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-