Pulse Boot - Pulse Tall Zippered Boot Black - NORMATEC INDUSTRIES LP

Duns Number:111448069

Device Description: Pulse Tall Zippered Boot Black

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More Product Details

Catalog Number

20001

Brand Name

Pulse Boot

Version/Model Number

Pulse Tall Zippered Boot Black

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K160608

Product Code Details

Product Code

IRP

Product Code Name

Massager, Powered Inflatable Tube

Device Record Status

Public Device Record Key

c65354f5-f2e1-439c-acec-1af04cee504d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 13, 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