Catalog Number

FE922K

Brand Name

AESCULAP

Version/Model Number

FE922K

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 19, 2017

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

HCH

Product Code Name

CLIP, ANEURYSM

Public Device Record Key

c8ad6ce2-fca4-4873-a8f2-8406fd8c59d6

Public Version Date

May 07, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-