Catalog Number

-

Brand Name

Face-Cradle

Version/Model Number

10-52000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

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

5de19b70-3433-4437-81f5-478acbef3697

Public Version Date

April 28, 2020

Public Version Number

1

DI Record Publish Date

April 20, 2020

Package DI Number

30641043520004

Quantity per Package

1

Contains DI Package

10641043520000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-