Derma Genesis Infusion D11-0358-101

GUDID 00818257022122

Multi Modality Micro-Exfolaition system

GENESIS BIOSYSTEMS, INC.

Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system

• Primary Device ID: 00818257022122
• NIH Device Record Key: 28aa43f9-2c7a-4235-b27b-828279a5a943
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Derma Genesis Infusion
• Version Model Number: D11-0358-101
• Catalog Number: D11-0358-101
• Company DUNS: 067933700
• Company Name: GENESIS BIOSYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com
• Phone: 9723157888
• Email: customerservice@genesisbiosystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818257022122 [Primary]

FDA Product Code

• GFE: Brush, Dermabrasion, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-01
• Device Publish Date: 2023-07-24

Devices Manufactured by GENESIS BIOSYSTEMS, INC.

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• 00818257022122 - Derma Genesis Infusion: 2023-08-01 Multi Modality Micro-Exfolaition system
• 00818257020074 - CoolBreeze: 2020-02-24 Cool Breeze LED Wand - Red
• 00818257020081 - CoolBreeze: 2020-02-24 Cool Breeze LED wand - Blue
• 00818257020012 - LipiVage®: 2018-03-29 LipiVage Harvester
• 00818257020029 - LipiVage®: 2018-03-29 LipiVage Harvester with cannula