Catalog Number

U12M45

Brand Name

easyEndoTM Lite Linear Cutting Stapler for Single Use

Version/Model Number

U12M45

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K210909,K210909

Product Code

GAG

Product Code Name

Stapler, Surgical

Public Device Record Key

09ae8b64-bcd7-4f81-883c-1cb302dafb0d

Public Version Date

August 18, 2021

Public Version Number

1

DI Record Publish Date

August 10, 2021

Package DI Number

16925776102585

Quantity per Package

1

Contains DI Package

06925776102588

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

paper box