TOTAL TILT TOP HEAD CENTERED

GUDID 00844505000239

TOTAL TILT TOP 3MM HEAD CENTERED 1MM DIA X 8MM L HA/OTOSIL

Grace Medical, Inc.

Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total Ossicular prosthesis, total

• Primary Device ID: 00844505000239
• NIH Device Record Key: f190249d-bb33-4fd2-a88e-2a713fee6eec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOTAL TILT TOP HEAD CENTERED
• Version Model Number: 200
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505000239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972815

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 [TOTAL TILT TOP HEAD CENTERED]

• 00844505000246: TOTAL TILT TOP 4MM HEAD CENTERED 1MM DIA X 8MM L HA/OTOSIL
• 00844505000239: TOTAL TILT TOP 3MM HEAD CENTERED 1MM DIA X 8MM L HA/OTOSIL