Catalog Number

-

Brand Name

Voss PronePositioner

Version/Model Number

P-3901

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K932187

Product Code

KIL

Product Code Name

Positioner, Socket

Public Device Record Key

bb884882-0d6d-4950-9a50-cf6d225e5955

Public Version Date

January 08, 2019

Public Version Number

4

DI Record Publish Date

January 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-