Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

B9-15934C

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)

Yes

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

7f72b283-801d-4886-b56b-e7fe21ae4e60

Public Version Date

January 15, 2021

Public Version Number

1

DI Record Publish Date

January 07, 2021

Package DI Number

20811870036235

Quantity per Package

20

Contains DI Package

00811870036231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA