DragonFly™ ANGLED ADAPTOR-15°

GUDID 00844505009744

DragonFly™, POWERED BY InvisiDrive™ ANGLED ADAPTOR 15° USED WITH 950-002 HANDPIECE

Grace Medical, Inc.

Burring power tool attachment

• Primary Device ID: 00844505009744
• NIH Device Record Key: d81c28b7-d843-43d2-8dd5-e6515a984c68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DragonFly™ ANGLED ADAPTOR-15°
• Version Model Number: 950-006-15
• 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: true
• Serial Number: false
• 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	00844505009744 [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

[00844505009744]

Moist Heat or Steam Sterilization

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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