TOTAL TILT TOP HEAD NOTCHED

GUDID 00844505000284

TOTAL TILT TOP 4MM HEAD NOTCHED 1MM DIA X 8MM L HA/OTOSIL

Grace Medical, Inc.

Ossicular prosthesis, total

• Primary Device ID: 00844505000284
• NIH Device Record Key: 8d484319-1b00-4dbe-a431-0b96cc718a6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOTAL TILT TOP HEAD NOTCHED
• Version Model Number: 205
• 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	00844505000284 [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: 4
• Public Version Date: 2020-03-23
• Device Publish Date: 2016-02-18

On-Brand Devices [TOTAL TILT TOP HEAD NOTCHED]

• 00844505000314: TOTAL TILT TOP 3.50MM HEAD NOTCHED 1MM DIA X 8MM L HA/OTOSIL
• 00844505000284: TOTAL TILT TOP 4MM HEAD NOTCHED 1MM DIA X 8MM L HA/OTOSIL
• 00844505000277: TOTAL TILT TOP 3.25MM HEAD NOTCHED 1MM DIA X 8MM L HA/OTOSIL