VIVE - Quad Cane Red - VIVE HEALTH LLC

Duns Number:047025993

Device Description: Quad Cane Red

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More Product Details

Catalog Number

-

Brand Name

VIVE

Version/Model Number

MOB1003RED

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

-

Product Code Details

Product Code

IPS

Product Code Name

Cane

Device Record Status

Public Device Record Key

8b41f32f-79be-403a-99bc-259de7f9900c

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 31, 2019

Additional Identifiers

Package DI Number

10818323026204

Quantity per Package

4

Contains DI Package

00818323026207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"VIVE HEALTH LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 480
2 A medical device with a moderate to high risk that requires special controls. 87