VMA Motion Normalizer - VMA Motion Normalizer (Console, Table, and - ORTHO KINEMATICS, INC.

Duns Number:932053221

Device Description: VMA Motion Normalizer (Console, Table, and Upright assemblies)

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More Product Details

Catalog Number

-

Brand Name

VMA Motion Normalizer

Version/Model Number

3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

87e94e30-5594-4e6b-845d-8181dad3a255

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

January 31, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO KINEMATICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 5