Catalog Number

US961

Brand Name

AESCULAP

Version/Model Number

US961

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 08, 2022

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

9a898e36-2a90-47c8-bd1e-f6b63c9e5b31

Public Version Date

July 12, 2022

Public Version Number

3

DI Record Publish Date

February 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-