PRECISE CENTERED PARTIAL

GUDID 00844505005500

PRECISE CENTERED PARTIAL 3.00MM LENGTH TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505005500
• NIH Device Record Key: 54549b21-85ee-4e44-b6d3-07a8a93ef810
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECISE CENTERED PARTIAL
• Version Model Number: 765-300
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505005500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061853

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-18

On-Brand Devices [PRECISE CENTERED PARTIAL]

• 00844505009119: PRECISE CENTERED PARTIAL 0.75MM LENGTH TITANIUM
• 00844505009102: PRECISE CENTERED PARTIAL 1.00MM LENGTH TITANIUM
• 00844505009096: PRECISE CENTERED PARTIAL 1.25MM LENGTH TITANIUM
• 00844505009089: PRECISE CENTERED PARTIAL 1.50MM LENGTH TITANIUM
• 00844505007078: PRECISE CENTERED PARTIAL 5.50MM LENGTH TITANIUM
• 00844505007061: PRECISE CENTERED PARTIAL 5.25MM LENGTH TITANIUM
• 00844505007054: PRECISE CENTERED PARTIAL 5.00MM LENGTH TITANIUM
• 00844505007047: PRECISE CENTERED PARTIAL 4.75MM LENGTH TITANIUM
• 00844505005562: PRECISE CENTERED PARTIAL 4.50MM LENGTH TITANIUM
• 00844505005555: PRECISE CENTERED PARTIAL 4.25MM LENGTH TITANIUM
• 00844505005548: PRECISE CENTERED PARTIAL 4.00MM LENGTH TITANIUM
• 00844505005531: PRECISE CENTERED PARTIAL 3.75MM LENGTH TITANIUM
• 00844505005524: PRECISE CENTERED PARTIAL 3.50MM LENGTH TITANIUM
• 00844505005517: PRECISE CENTERED PARTIAL 3.25MM LENGTH TITANIUM
• 00844505005500: PRECISE CENTERED PARTIAL 3.00MM LENGTH TITANIUM
• 00844505005494: PRECISE CENTERED PARTIAL 2.75MM LENGTH TITANIUM
• 00844505005487: PRECISE CENTERED PARTIAL 2.50MM LENGTH TITANIUM
• 00844505005470: PRECISE CENTERED PARTIAL 2.25MM LENGTH TITANIUM
• 00844505005463: PRECISE CENTERED PARTIAL 2.00MM LENGTH TITANIUM
• 00844505005456: PRECISE CENTERED PARTIAL 1.75MM LENGTH TITANIUM