Catalog Number

0108

Brand Name

rack-n-stack

Version/Model Number

0108

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FWZ

Product Code Name

Operating Room Accessories Table Tray

Public Device Record Key

ae915249-c8e0-4f60-9e57-daf6d4628bde

Public Version Date

September 22, 2022

Public Version Number

1

DI Record Publish Date

September 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-