PARTIAL TILT TOP 3.25MM HEAD OFFSET

GUDID 00844505000345

PARTIAL TILT TOP 3.25MM HEAD OFFSET 1.12MM ID X 6MM L HA/OTOSIL

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505000345
• NIH Device Record Key: b508deb8-c914-432c-a664-f03bef13626c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PARTIAL TILT TOP 3.25MM HEAD OFFSET
• Version Model Number: 252
• 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	00844505000345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972815

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: 2020-03-23
• Device Publish Date: 2016-02-18

Devices Manufactured by Grace Medical, Inc.

• 00844505014694 - SKULL BASE: 2025-10-06 SKULL BASE ROUND KNIFE ANGLED 45° STAINLESS STEEL
• 00844505014700 - SKULL BASE: 2025-10-06 RIGHT ANGLE SIZING ROD STAINLESS STEEL
• 00844505014717 - SKULL BASE: 2025-10-06 DOUBLE-ENDED DISSECTOR STRAIGHT CUEVA AND SPOON STAINLESS STEEL
• 00844505014724 - SKULL BASE: 2025-10-06 EXTENDED THOMASSIN DISSECTOR DOUBLE-ENDED STAINLESS STEEL
• 00844505014502 - TITANIUM PISTON: 2025-09-26 TITANIUM PISTON 0.6MM DIA X 5.75MM L TITANIUM/RIBBON
• 00844505014687 - GRACE MEDICAL FLUOROPLASTIC PISTON: 2025-09-26 FLUOROPLASTIC PISTON 0.6MM DIA X 5.50MM L
• 00844505014489 - ECLIPSE PISTON: 2025-08-13 ECLIPSE PISTON 0.5MM DIA X 3.50MM L NITINOL/FLUOROPLASTIC
• 00844505014519 - TITANIUM PISTON: 2025-08-13 TITANIUM PISTON 0.4MM DIA X 5.75MM L TITANIUM/RIBBON