NormaTec MVP Pro Upper Body Recovery Package - MVP Pro Recovery Package - Upper Body - NORMATEC INDUSTRIES LP

Duns Number:111448069

Device Description: MVP Pro Recovery Package - Upper Body

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More Product Details

Catalog Number

40410

Brand Name

NormaTec MVP Pro Upper Body Recovery Package

Version/Model Number

MVP Pro Recovery Package - Upper Body

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K013436

Product Code Details

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Device Record Status

Public Device Record Key

73c9e480-25df-4222-b50b-bab9d6f1c21e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NORMATEC INDUSTRIES LP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 202