Catalog Number

SYK41-228-11

Brand Name

Head Positioners

Version/Model Number

SYK41-228-11

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)

-

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

063fbc60-cfac-4d47-b0f8-171e00d2cc42

Public Version Date

December 10, 2019

Public Version Number

1

DI Record Publish Date

December 02, 2019

Package DI Number

00850013699216

Quantity per Package

12

Contains DI Package

10850013699213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case