Catalog Number

-

Brand Name

ACCUTRAY

Version/Model Number

5200050B

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

OFT

Product Code Name

Spinal epidural anesthesia kit

Public Device Record Key

dff1b131-92fd-40a7-872d-4c91dd5244a9

Public Version Date

May 20, 2020

Public Version Number

1

DI Record Publish Date

May 12, 2020

Package DI Number

20809160283704

Quantity per Package

24

Contains DI Package

10809160283707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-