Catalog Number

-

Brand Name

OrthoScan Pulse Mini C-arm

Version/Model Number

1000-0004-FD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

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

K133174

Product Code

MQB

Product Code Name

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Public Device Record Key

d7a9b875-2d93-4934-8685-0f34bbcf5e87

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-