T-SHAPE 2

GUDID 08053782383283

B&M SRL MARKETING NEL BENESSERE

Multi-modality skin contouring system

• Primary Device ID: 08053782383283
• NIH Device Record Key: dd6f340f-b7f4-439c-89bb-2a6bc6efe4e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-SHAPE 2
• Version Model Number: T-SHAPE 2
• Company DUNS: 445139129
• Company Name: B&M SRL MARKETING NEL BENESSERE
• 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	08053782383283 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231092

FDA Product Code

• NUV: Massager, Vacuum, Light Induced Heating

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: 2025-04-21
• Device Publish Date: 2025-04-11

Devices Manufactured by B&M SRL MARKETING NEL BENESSERE

• 08053782383313 - INFRABALDAN: 2025-05-08
• 08053782383283 - T-SHAPE 2: 2025-04-21
• 08053782383283 - T-SHAPE 2: 2025-04-21