miraDry na

GUDID 00853419006022

bioTip

MIRAMAR LABS, INC.

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: 00853419006022
• NIH Device Record Key: 752dc4fb-557f-4f1f-86eb-c63ea77aa581
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: miraDry
• Version Model Number: MD4000-BT
• Catalog Number: na
• Company DUNS: 008226764
• Company Name: MIRAMAR LABS, INC.
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853419006022 [Primary]

FDA Product Code

• MWY: System,Microwave,Hair Removal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-30

On-Brand Devices [miraDry]

• 00853419006039: bioTip
• 00853419006022: bioTip
• 00853419006015: Handpiece
• 00853419006008: Console