Catalog Number

-

Brand Name

Custom Healthcare Systems, Inc.

Version/Model Number

L4000

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

28b09066-70fc-4d54-85c9-8d3de86b04e8

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

May 29, 2019

Package DI Number

20811870032930

Quantity per Package

5

Contains DI Package

00811870032936

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA