VQ ORTHOCARE - CATALYST PROPEL OA OTS L LG, ANTERIOR CUFF/ATC - V Q Orthocare

Duns Number:601204902

Device Description: CATALYST PROPEL OA OTS L LG, ANTERIOR CUFF/ATC

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More Product Details

Catalog Number

-

Brand Name

VQ ORTHOCARE

Version/Model Number

07-41403-001

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

IQI

Product Code Name

Orthosis, Limb Brace

Device Record Status

Public Device Record Key

f5f75b0d-47b8-4de3-993b-8b6dd4ee2ef8

Public Version Date

August 30, 2022

Public Version Number

3

DI Record Publish Date

March 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"V Q ORTHOCARE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 170
2 A medical device with a moderate to high risk that requires special controls. 30