DragonFly™, POWERED BY InvisiDrive™ HANDPIECE

GUDID 00844505009713

DragonFly™, POWERED BY InvisiDrive™ HANDPIECE - USED WITH 950-003 FOOTSWITCH

Grace Medical, Inc.

Surgical power tool system handpiece, rotary, rechargeable battery-powered

• Primary Device ID: 00844505009713
• NIH Device Record Key: 0620c302-8455-4171-8fdd-d3e4665dd7d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DragonFly™, POWERED BY InvisiDrive™ HANDPIECE
• Version Model Number: 950-002
• Company DUNS: 030849173
• Company Name: Grace Medical, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505009713 [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: true
• Device Is Sterile: false

[00844505009713]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-09-22

Devices Manufactured by Grace Medical, Inc.

• 00844505014694 - SKULL BASE: 2025-10-06 SKULL BASE ROUND KNIFE ANGLED 45° STAINLESS STEEL
• 00844505014700 - SKULL BASE: 2025-10-06 RIGHT ANGLE SIZING ROD STAINLESS STEEL
• 00844505014717 - SKULL BASE: 2025-10-06 DOUBLE-ENDED DISSECTOR STRAIGHT CUEVA AND SPOON STAINLESS STEEL
• 00844505014724 - SKULL BASE: 2025-10-06 EXTENDED THOMASSIN DISSECTOR DOUBLE-ENDED STAINLESS STEEL
• 00844505014502 - TITANIUM PISTON: 2025-09-26 TITANIUM PISTON 0.6MM DIA X 5.75MM L TITANIUM/RIBBON
• 00844505014687 - GRACE MEDICAL FLUOROPLASTIC PISTON: 2025-09-26 FLUOROPLASTIC PISTON 0.6MM DIA X 5.50MM L
• 00844505014489 - ECLIPSE PISTON: 2025-08-13 ECLIPSE PISTON 0.5MM DIA X 3.50MM L NITINOL/FLUOROPLASTIC
• 00844505014519 - TITANIUM PISTON: 2025-08-13 TITANIUM PISTON 0.4MM DIA X 5.75MM L TITANIUM/RIBBON