PRECISE CENTERED TOTAL

GUDID 00844505005302

PRECISE CENTERED TOTAL 3.50MM LENGTH TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, total

• Primary Device ID: 00844505005302
• NIH Device Record Key: 70d25f2c-fc61-4b84-939b-a24d53549ec0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECISE CENTERED TOTAL
• Version Model Number: 705-350
• 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: 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
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com
• Phone: +1(866)472-2363
• Email: info@gracemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505005302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061853

FDA Product Code

• ETA: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-18

On-Brand Devices [PRECISE CENTERED TOTAL]

• 00844505005449: PRECISE CENTERED TOTAL 7.00MM LENGTH TITANIUM
• 00844505005432: PRECISE CENTERED TOTAL 6.75MM LENGTH TITANIUM
• 00844505005425: PRECISE CENTERED TOTAL 6.50MM LENGTH TITANIUM
• 00844505005418: PRECISE CENTERED TOTAL 6.25MM LENGTH TITANIUM
• 00844505005401: PRECISE CENTERED TOTAL 6.00MM LENGTH TITANIUM
• 00844505005395: PRECISE CENTERED TOTAL 5.75MM LENGTH TITANIUM
• 00844505005388: PRECISE CENTERED TOTAL 5.50MM LENGTH TITANIUM
• 00844505005371: PRECISE CENTERED TOTAL 5.25MM LENGTH TITANIUM
• 00844505005364: PRECISE CENTERED TOTAL 5.00MM LENGTH TITANIUM
• 00844505005357: PRECISE CENTERED TOTAL 4.75MM LENGTH TITANIUM
• 00844505005340: PRECISE CENTERED TOTAL 4.50MM LENGTH TITANIUM
• 00844505005333: PRECISE CENTERED TOTAL 4.25MM LENGTH TITANIUM
• 00844505005326: PRECISE CENTERED TOTAL 4.00MM LENGTH TITANIUM
• 00844505005319: PRECISE CENTERED TOTAL 3.75MM LENGTH TITANIUM
• 00844505005302: PRECISE CENTERED TOTAL 3.50MM LENGTH TITANIUM
• 00844505005296: PRECISE CENTERED TOTAL 3.25MM LENGTH TITANIUM