PRECISE OFFSET TOTAL

GUDID 00844505005654

PRECISE OFFSET TOTAL 5.00MM LENGTH TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, total

• Primary Device ID: 00844505005654
• NIH Device Record Key: 5a6d0cd9-34de-4b10-839e-b50637216fb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRECISE OFFSET TOTAL
• Version Model Number: 700-500
• 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	00844505005654 [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: 4
• Public Version Date: 2020-03-30
• Device Publish Date: 2016-02-18

On-Brand Devices [PRECISE OFFSET TOTAL]

• 00844505005739: PRECISE OFFSET TOTAL 7.00MM LENGTH TITANIUM
• 00844505005722: PRECISE OFFSET TOTAL 6.75MM LENGTH TITANIUM
• 00844505005715: PRECISE OFFSET TOTAL 6.50MM LENGTH TITANIUM
• 00844505005708: PRECISE OFFSET TOTAL 6.25MM LENGTH TITANIUM
• 00844505005692: PRECISE OFFSET TOTAL 6.00MM LENGTH TITANIUM
• 00844505005685: PRECISE OFFSET TOTAL 5.75MM LENGTH TITANIUM
• 00844505005678: PRECISE OFFSET TOTAL 5.50MM LENGTH TITANIUM
• 00844505005661: PRECISE OFFSET TOTAL 5.25MM LENGTH TITANIUM
• 00844505005654: PRECISE OFFSET TOTAL 5.00MM LENGTH TITANIUM
• 00844505005647: PRECISE OFFSET TOTAL 4.75MM LENGTH TITANIUM
• 00844505005630: PRECISE OFFSET TOTAL 4.50MM LENGTH TITANIUM
• 00844505005623: PRECISE OFFSET TOTAL 4.25MM LENGTH TITANIUM
• 00844505005616: PRECISE OFFSET TOTAL 4.00MM LENGTH TITANIUM
• 00844505005609: PRECISE OFFSET TOTAL 3.75MM LENGTH TITANIUM
• 00844505005593: PRECISE OFFSET TOTAL 3.50MM LENGTH TITANIUM
• 00844505005586: PRECISE OFFSET TOTAL 3.25MM LENGTH TITANIUM
• 00844505005579: PRECISE OFFSET TOTAL 3MM LENGTH TITANIUM