Catalog Number

CCS29

Brand Name

NA

Version/Model Number

CCS29

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

-

Product Code

GDW

Product Code Name

STAPLE, IMPLANTABLE

Public Device Record Key

1d113198-dc92-4fb0-a349-ab7dc4a756c6

Public Version Date

July 08, 2019

Public Version Number

6

DI Record Publish Date

August 24, 2015

Package DI Number

30705036014069

Quantity per Package

10

Contains DI Package

20705036014062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE