Catalog Number

-

Brand Name

AccuTray™

Version/Model Number

5200100

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

ec6532fb-6999-4ce1-8551-6ca70f0cb3a4

Public Version Date

December 12, 2019

Public Version Number

4

DI Record Publish Date

August 26, 2016

Package DI Number

20809160001643

Quantity per Package

24

Contains DI Package

10809160001646

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-