Catalog Number

-

Brand Name

Face-Cradle

Version/Model Number

10-52003

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

Yes

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

6e79598c-ce30-4b5f-a683-443960d8f1c0

Public Version Date

September 10, 2019

Public Version Number

2

DI Record Publish Date

May 31, 2018

Package DI Number

30641043520035

Quantity per Package

5

Contains DI Package

10641043520031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-