Catalog Number

V10705

Brand Name

BREG

Version/Model Number

NOVAPLUS PC CUBE W/ KNEE PAD

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

-

Product Code

ILO

Product Code Name

Pack, Hot Or Cold, Water Circulating

Public Device Record Key

85e9afed-fee7-4bba-9237-a4ecb85cc031

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 15, 2016

Package DI Number

20672736021464

Quantity per Package

4

Contains DI Package

00672736021446

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bulk 4 pack