Catalog Number

-

Brand Name

AEON

Version/Model Number

AESR45P

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

bff89ec2-db79-4bf4-bc02-2ad836017d70

Public Version Date

January 29, 2021

Public Version Number

2

DI Record Publish Date

August 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-