Catalog Number

-

Brand Name

Single Use Circular Stapler

Version/Model Number

CSB34

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"

-

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

K162707,K162707

Product Code

GDW

Product Code Name

Staple, Implantable

Public Device Record Key

e333b3a8-11cb-4104-a94c-4d085bf69df2

Public Version Date

June 24, 2019

Public Version Number

1

DI Record Publish Date

June 14, 2019

Package DI Number

16946912216065

Quantity per Package

6

Contains DI Package

06946912216068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-