Catalog Number

-

Brand Name

AEON

Version/Model Number

AESH060

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"

Yes

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

K171589,K171589

Product Code

GDW

Product Code Name

Staple, Implantable

Public Device Record Key

2e151e03-df83-49d1-bfa5-829d4fbfb4c3

Public Version Date

February 09, 2021

Public Version Number

1

DI Record Publish Date

February 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-