Catalog Number

-

Brand Name

Custom Healthcare Systems Inc.

Version/Model Number

A3475V-5

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

OJK

Product Code Name

Eye Tray

Public Device Record Key

5e8fcc79-67ec-4a91-97c8-7513ca862850

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

July 26, 2018

Package DI Number

20811870032626

Quantity per Package

30

Contains DI Package

00811870032622

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

N/A