Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

B9-19784

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

ed5cceec-1fcd-4977-a321-2f6925bebaef

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

July 17, 2020

Package DI Number

20811870034842

Quantity per Package

25

Contains DI Package

00811870034848

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA