DragonFly™ Skinny BUR, 100MM x 1.0MM

GUDID 00844505012560

DragonFly™ ROUND DIAMOND "Skinny" BUR 100MM LENGTH, 1.0MM Ø, Rx ONLY-USED WITH 950-002 HANDPIECE

Grace Medical, Inc.

Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use Diamond ENT bur, single-use

• Primary Device ID: 00844505012560
• NIH Device Record Key: fc545c31-4675-40f4-b2ad-7c7f72a905f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DragonFly™ Skinny BUR, 100MM x 1.0MM
• Version Model Number: 951-100-010-SB
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com
• Phone: +1(866)472-2362
• Email: info@gracemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505012560 [Primary]

FDA Product Code

• EQJ: Bur, Ear, Nose And Throat

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-08
• Device Publish Date: 2021-10-29

Devices Manufactured by Grace Medical, Inc.

• 10844505014394 - TOUMA VENT TUBE W/ TAB: 2024-01-31 MODIFIED TOUMA VENT TUBE W/ TAB 1.27MM ID SILICONE
• 10844505014004 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 5 PACK
• 10844505014042 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
• 10844505014080 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 10 PACK
• 10108445050141 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 10 PACK
• 10844505014165 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 30 PACK
• 10844505014189 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 30 PACK
• 10844505014240 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 60 PACK