Catalog Number

ECH45L

Brand Name

ECHELON

Version/Model Number

ECH45L

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

GAG

Product Code Name

Stapler, surgical

Public Device Record Key

5338c129-6706-4cdf-966a-40a4c8b3bf79

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Package DI Number

20705036034961

Quantity per Package

3

Contains DI Package

10705036034964

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX