Catalog Number

FO940R

Brand Name

AESCULAP

Version/Model Number

FO940R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 26, 2021

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

-

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

HWQ

Product Code Name

PASSER

Public Device Record Key

0061d97f-7698-41df-94ff-2284420e2258

Public Version Date

June 23, 2021

Public Version Number

2

DI Record Publish Date

April 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-