DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS

GUDID 00844505013109

DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS 1.00MM FIXED LENGTH HA/TITANIUM/NITINOL

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505013109
• NIH Device Record Key: c35417f2-1e1b-4648-b957-bf20d585debf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS
• Version Model Number: 692-100
• 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
• 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
• Phone: +1(866)472-2363
• Email: info@gracemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505013109 [Primary]

FDA Product Code

• ETB: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-28
• Device Publish Date: 2022-09-20

On-Brand Devices [DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS]

• 00844505013802: DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS 1.50MM FIXED LENGTH HA/TITANIUM/NITINOL
• 00844505013796: DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS 1.25MM FIXED LENGTH HA/TITANIUM/NITINOL
• 00844505013109: DORNHOFFER NYTEBYTE PARTIAL W/WINDOWS 1.00MM FIXED LENGTH HA/TITANIUM/NITINOL