Catalog Number

777004

Brand Name

Devon

Version/Model Number

777004

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CCX

Product Code Name

SUPPORT, PATIENT POSITION

Public Device Record Key

67eecd4f-e50f-4785-9747-f6121505e9d7

Public Version Date

February 15, 2019

Public Version Number

2

DI Record Publish Date

June 30, 2018

Package DI Number

20884527004031

Quantity per Package

4

Contains DI Package

10884527004034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE