Catalog Number

-

Brand Name

ACCUTRAY

Version/Model Number

5200063B

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

db9e0a5f-c991-4edc-a7e4-129ce6de5360

Public Version Date

July 24, 2020

Public Version Number

1

DI Record Publish Date

July 16, 2020

Package DI Number

20809160287931

Quantity per Package

24

Contains DI Package

10809160287934

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-