DragonFly™ FOOTSWITCH

GUDID 00844505009737

DragonFly™ SURGICAL DRILL SYSTEM POWERED BY Invisidrive™ FOOTSWITCH

Grace Medical, Inc.

Foot-switch, electrical

• Primary Device ID: 00844505009737
• NIH Device Record Key: 7e883e04-ba36-4668-b0bf-d115cb336e6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DragonFly™ FOOTSWITCH
• Version Model Number: 950-003
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: +1(866)472-2363
• Email: info@gracemedical.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505009737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161376

FDA Product Code

• ERL: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

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: 2018-10-23
• Device Publish Date: 2018-09-22

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