HA PARTIAL PROSTHESIS

GUDID 00844505000147

HA PARTIAL PROSTHESIS 4MM CENTERED HEAD 1.17MM ID. X 5MM LENGTH

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505000147
• NIH Device Record Key: 97c5d3f5-d0e9-45c9-8aa5-2c027452eed7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HA PARTIAL PROSTHESIS
• Version Model Number: 151
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00844505000147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963752

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

On-Brand Devices [HA PARTIAL PROSTHESIS]

• 00844505000161: HA PARTIAL PROSTHESIS 4MM NOTCHED HEAD 1.17MM ID. X 5MM LENGTH
• 00844505000154: HA PARTIAL PROSTHESIS 4MM OFFSET HEAD 1.17MM ID. X 5MM LENGTH
• 00844505000147: HA PARTIAL PROSTHESIS 4MM CENTERED HEAD 1.17MM ID. X 5MM LENGTH
• 00844505000130: HA PARTIAL PROSTHESIS 3MM CENTERED HEAD 1.17MM ID. X 5MM LENGTH