VIVACE Microneedle Cartridge

GUDID 08800017100234

shenb Co., Ltd.

Radio-frequency skin surface treatment system

• Primary Device ID: 08800017100234
• NIH Device Record Key: c55ae95a-8e68-4d21-8df5-b3510c489280
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIVACE Microneedle Cartridge
• Version Model Number: SH-TIP
• Company DUNS: 690425442
• Company Name: shenb Co., Ltd.
• Device Count: 10
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800017100234 [Primary]
GS1	08800017100340 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150409

FDA Product Code

• OUH: Skin Resurfacing Rf Applicator

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-21
• Device Publish Date: 2019-10-11

Devices Manufactured by shenb Co., Ltd.

• 08800017101118 - PlaDuo System: 2023-11-09
• 08800017100883 - VYBE RF: 2022-09-27 Brand Name: VYBE RF (VIVACE) Model: VYBE RF
• 08800017100579 - Sterile Micro Needle Cartridge: 2021-12-16 Blister Pack
• 08800017100616 - Sterile Micro Needle Cartridge: 2021-12-16 Blister Pack
• 08800017100647 - Sterile Micro Needle Cartridge: 2021-12-16 Blister Pack
• 08800017100678 - Sterile Micro Needle Cartridge: 2021-12-16 Blister Pack
• 08800017100753 - Sterile Micro Needle Cartridge: 2021-12-16 Blister Pack
• 08800017100784 - Sterile Micro Needle Cartridge: 2021-12-16 Blister Pack