miraDry na

GUDID 00853419006022

bioTip

MIRAMAR LABS, INC.

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