Catalog Number

-

Brand Name

CUSTOM HEALTHCARE SYSTEMS, INC

Version/Model Number

3805396

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

f0ae5fd9-c352-4028-b25e-558a884d5788

Public Version Date

April 24, 2020

Public Version Number

1

DI Record Publish Date

April 16, 2020

Package DI Number

20811870034729

Quantity per Package

10

Contains DI Package

00811870034725

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA