Catalog Number

CS34

Brand Name

CQ'ENCE Circular Stapler 34mm

Version/Model Number

CS34

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K120179

Product Code

GDW

Product Code Name

Staple, Implantable

Public Device Record Key

3d26717c-08b9-4828-9a6d-dc0a9ff62fff

Public Version Date

May 07, 2019

Public Version Number

5

DI Record Publish Date

October 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-