Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

CUS1174

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

LRO

Product Code Name

General Surgery Tray

Public Device Record Key

3ec3b99e-67ab-4e3a-9879-8c2ff43b14ce

Public Version Date

February 06, 2020

Public Version Number

1

DI Record Publish Date

January 29, 2020

Package DI Number

20811870034293

Quantity per Package

10

Contains DI Package

00811870034299

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-