Vector Elite - Vector Gait and Safety System - BIONESS INC.

Duns Number:182287727

Device Description: Vector Gait and Safety System

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More Product Details

Catalog Number

-

Brand Name

Vector Elite

Version/Model Number

VEC-1000

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

-

Product Code Details

Product Code

BXB

Product Code Name

EXERCISER, POWERED

Device Record Status

Public Device Record Key

7820fdeb-f6ae-4c68-b122-8f790ca948f4

Public Version Date

May 20, 2020

Public Version Number

3

DI Record Publish Date

December 07, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIONESS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 72