GRACE PISTON

GUDID 00844505000949

GRACE PISTON 0.4MM DIA X 6.00MM L PLATINUM RIBBON/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505000949
• NIH Device Record Key: ea60ffd1-568d-4ad7-b5fd-30234b2566ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRACE PISTON
• Version Model Number: 412-600
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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)472-2363
• Email: info@gracemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505000949 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060518

FDA Product Code

• ETB: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-18
• Device Publish Date: 2016-02-18

On-Brand Devices [GRACE PISTON]

• 00844505006392: GRACE PISTON 0.6MM DIA X 5.00MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006385: GRACE PISTON 0.6MM DIA X 4.75MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006378: GRACE PISTON 0.6MM DIA X 4.50MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006361: GRACE PISTON 0.6MM DIA X 4.25MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006354: GRACE PISTON 0.6MM DIA X 4.00MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006347: GRACE PISTON 0.6MM DIA X 3.75MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006316: GRACE PISTON 0.5MM DIA X 5.00MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006309: GRACE PISTON 0.5MM DIA X 4.75MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006293: GRACE PISTON 0.5MM DIA X 4.50MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006286: GRACE PISTON 0.5MM DIA X 4.25MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006279: GRACE PISTON 0.5MM DIA X 4.00MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006262: GRACE PISTON 0.5MM DIA X 3.75MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505006194: GRACE PISTON 0.4MM DIA X 5.00MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505000949: GRACE PISTON 0.4MM DIA X 6.00MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505000932: GRACE PISTON 0.4MM DIA X 4.75MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505000925: GRACE PISTON 0.4MM DIA X 4.50MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505000918: GRACE PISTON 0.4MM DIA X 4.25MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505000901: GRACE PISTON 0.4MM DIA X 4.00MM L PLATINUM RIBBON/FLUOROPLASTIC
• 00844505000895: GRACE PISTON 0.4MM DIA X 3.75MM L PLATINUM RIBBON/FLUOROPLASTIC