LipiVage® - LipiVage Harvester - GENESIS BIOSYSTEMS, INC.

Duns Number:067933700

Device Description: LipiVage Harvester

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More Product Details

Catalog Number

-

Brand Name

LipiVage®

Version/Model Number

D11-0290-108

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

Yes

Prescription Use (Rx)

-

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

MUU

Product Code Name

System, Suction, Lipoplasty

Device Record Status

Public Device Record Key

d09c4a24-7f89-406a-a976-f52968ff5476

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 21, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GENESIS BIOSYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4