TITANIUM PISTON

GUDID 00844505007085

TITANIUM PISTON 0.6MM DIA X 5.00MM L TITANIUM/RIBBON

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505007085
• NIH Device Record Key: aeb5760d-d85d-4ec1-8ceb-429cdd483289
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TITANIUM PISTON
• Version Model Number: 461-500
• 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	00844505007085 [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: 2020-05-04
• Device Publish Date: 2016-02-18

On-Brand Devices [TITANIUM PISTON]

• 00844505007108: TITANIUM PISTON 0.6MM DIA X 5.50MM L TITANIUM/RIBBON
• 00844505007092: TITANIUM PISTON 0.6MM DIA X 5.25MM L TITANIUM/RIBBON
• 00844505007085: TITANIUM PISTON 0.6MM DIA X 5.00MM L TITANIUM/RIBBON
• 00844505006880: TITANIUM PISTON 0.4MM DIA X 5.50MM L TITANIUM/RIBBON
• 00844505006873: TITANIUM PISTON 0.4MM DIA X 5.25MM L TITANIUM/RIBBON
• 00844505006866: TITANIUM PISTON 0.4MM DIA X 5.00MM L TITANIUM/RIBBON
• 00844505006859: TITANIUM PISTON 0.4MM DIA X 4.75MM L TITANIUM/RIBBON
• 00844505006842: TITANIUM PISTON 0.4MM DIA X 4.50MM L TITANIUM/RIBBON
• 00844505006835: TITANIUM PISTON 0.4MM DIA X 4.25MM L TITANIUM/RIBBON
• 00844505006828: TITANIUM PISTON 0.4MM DIA X 4.00MM L TITANIUM/RIBBON
• 00844505006811: TITANIUM PISTON 0.4MM DIA X 3.75MM L TITANIUM/RIBBON
• 00844505006804: TITANIUM PISTON 0.4MM DIA X 3.50MM L TITANIUM/RIBBON
• 00844505006644: TITANIUM PISTON 0.6MM DIA X 4.75MM L TITANIUM/RIBBON
• 00844505006637: TITANIUM PISTON 0.6MM DIA X 4.50MM L TITANIUM/RIBBON
• 00844505006620: TITANIUM PISTON 0.6MM DIA X 4.25MM L TITANIUM/RIBBON
• 00844505006613: TITANIUM PISTON 0.6MM DIA X 4.00MM L TITANIUM/RIBBON
• 00844505006606: TITANIUM PISTON 0.6MM DIA X 3.75MM L TITANIUM/RIBBON
• 00844505006590: TITANIUM PISTON 0.6MM DIA X 3.50MM L TITANIUM/RIBBON
• 00844505001007: TITANIUM PISTON 0.5MM DIA X 4.75MM L TITANIUM
• 00844505000987: TITANIUM PISTON 0.5MM DIA X 4.50MM L TITANIUM/RIBBON
• 00844505000963: TITANIUM PISTON 0.5MM DIA X 4.25MM L TITANIUM/RIBBON
• 00844505000956: TITANIUM PISTON 0.5MM DIA X 4.00MM L TITANIUM