VYBE RF

GUDID 08800017100883

Brand Name: VYBE RF (VIVACE) Model: VYBE RF

shenb Co., Ltd.

Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator Electrosurgical system generator

• Primary Device ID: 08800017100883
• NIH Device Record Key: 045ecc87-9c9c-4ec4-897f-5ffda88b196c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VYBE RF
• Version Model Number: VYBE RF
• Company DUNS: 690425442
• Company Name: shenb Co., Ltd.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	08800017100883 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193070

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2022-09-27
• Device Publish Date: 2022-09-19

Devices Manufactured by shenb Co., Ltd.

• 08800017101118 - PlaDuo System: 2023-11-09
• 08800017100883 - VYBE RF: 2022-09-27Brand Name: VYBE RF (VIVACE) Model: VYBE RF
• 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