D-ACTOR®

GUDID 07630039101060

Pulse Activation Therapy System

Storz Medical AG

Electric massager

• Primary Device ID: 07630039101060
• NIH Device Record Key: 88000f1f-e7ac-4d6a-9a80-a20430de443e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-ACTOR®
• Version Model Number: 100
• Company DUNS: 481967776
• Company Name: Storz Medical AG
• 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	07630039101060 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173692

FDA Product Code

• ISA: Massager, Therapeutic, Electric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-01-23
• Device Publish Date: 2018-10-28

On-Brand Devices [D-ACTOR®]

• 07630039101121: Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy.
• 07630039101060: Pulse Activation Therapy System
• 07630039101039: 200
• 07630039100476: Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy.
• 07630039100414: Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy.
• 07630039100407: Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy.
• 07630039100391: Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy.