Catalog Number

-

Brand Name

ACCUTRAY

Version/Model Number

5200210

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 12, 2016

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

f8dcc1f4-ccfa-4dd5-8204-2f0d93507405

Public Version Date

August 14, 2020

Public Version Number

4

DI Record Publish Date

September 14, 2016

Package DI Number

20809160103606

Quantity per Package

24

Contains DI Package

10809160103609

Package Discontinue Date

October 12, 2016

Package Status

Not in Commercial Distribution

Package Type

-