Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

Nine011

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

OJH

Product Code Name

Orthopedic Tray

Public Device Record Key

bae171c6-b54f-4fc8-a4ea-734ea723c215

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

June 04, 2020

Package DI Number

20811870034811

Quantity per Package

4

Contains DI Package

00811870034817

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA