Catalog Number

-

Brand Name

CUSTOM HEALTHCARE SYSTEMS INC

Version/Model Number

UVA-19219

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

OGD

Product Code Name

Custom Anesthesia Tray

Public Device Record Key

fa850f2b-900d-4593-8a1e-e9af31479e9b

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

April 01, 2019

Package DI Number

20811870035047

Quantity per Package

60

Contains DI Package

00811870035043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA