Catalog Number

ECS25B

Brand Name

N/A

Version/Model Number

ECS25B

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

K201280,K201280

Product Code

GDW

Product Code Name

Staple, implantable

Public Device Record Key

ca136c90-fa7c-4f7f-90ee-64783618030b

Public Version Date

January 28, 2022

Public Version Number

1

DI Record Publish Date

January 20, 2022

Package DI Number

20705036022920

Quantity per Package

3

Contains DI Package

10705036022923

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX