Revolve ENVI 600 Advanced Adipose System RV0001E600

GUDID M328RV0001E6000

Tissue Processing System

LIFECELL CORPORATION

Surgical suction system collection container, single-use

• Primary Device ID: M328RV0001E6000
• NIH Device Record Key: 35130871-c9e9-4558-8804-1ec2d158fdc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revolve ENVI 600 Advanced Adipose System
• Version Model Number: RV0001E600
• Catalog Number: RV0001E600
• Company DUNS: 157224205
• Company Name: LIFECELL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818410012410 [Primary]
HIBCC	M328RV0001E6000 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163647

FDA Product Code

• MUU: System, Suction, Lipoplasty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-05-06
• Device Publish Date: 2017-12-18

Devices Manufactured by LIFECELL CORPORATION

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• M32803030030 - Conexa Reconstructive Tissue Matrix: 2022-06-10 Conexa 3cm x 3cm Thick Pliable Product, Rotator Cuff
• M32804040040 - Conexa Reconstructive Tissue Matrix: 2022-06-10 Conexa 4cm x 4cm Thin Firm Product, Tendon
• M32805050030 - Conexa Reconstructive Tissue Matrix: 2022-06-10 Conexa 5cm x 5cm Thick Pliable Product, Rotator Cuff
• M32805100030 - Conexa Reconstructive Tissue Matrix: 2022-06-10 Conexa 5cm x 10cm Thick Pliable Product, Rotator Cuff
• M32805100040 - Conexa Reconstructive Tissue Matrix: 2022-06-10 Conexa 5cm x 10cm Thin Firm Product, Tendon
• M32806060040 - Conexa Reconstructive Tissue Matrix: 2022-06-10 Conexa 6cm x 6cm Thin Firm Product, Tendon
• M32803140060 - Strattice Reconstructive Tissue Matrix BPS: 2021-05-17 BPS Strattice 3 cm x 14 cm - Pliable