Revolve ENVI 600 Advanced Adipose System RV0001E600

GUDID M328RV0001E6000

Tissue Processing System

LIFECELL CORPORATION

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Primary Device IDM328RV0001E6000
NIH Device Record Key35130871-c9e9-4558-8804-1ec2d158fdc8
Commercial Distribution StatusIn Commercial Distribution
Brand NameRevolve ENVI 600 Advanced Adipose System
Version Model NumberRV0001E600
Catalog NumberRV0001E600
Company DUNS157224205
Company NameLIFECELL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100818410012410 [Primary]
HIBCCM328RV0001E6000 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUUSystem, Suction, Lipoplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-05-06
Device Publish Date2017-12-18

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