Catalog Number

A4340ASDF

Brand Name

Centesis Procedure Tray

Version/Model Number

A4340ASDF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

OJT

Product Code Name

Aspiration Tray

Public Device Record Key

9b4eb5c0-b531-4446-9ccf-6473603ea0ef

Public Version Date

July 28, 2022

Public Version Number

1

DI Record Publish Date

July 20, 2022

Package DI Number

20886333220711

Quantity per Package

10

Contains DI Package

00886333220717

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box