Catalog Number

CDH29P

Brand Name

ECHELON CIRCULAR

Version/Model Number

CDH29P

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

-

Product Code

GDW

Product Code Name

Staple, implantable

Public Device Record Key

7e5c9b1d-0af5-40d9-b8a2-3be59ab35ed5

Public Version Date

October 30, 2019

Public Version Number

2

DI Record Publish Date

March 14, 2019

Package DI Number

20705036015380

Quantity per Package

3

Contains DI Package

10705036015383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX