PARTIAL TILT TOP 3MM HEAD CENTERED

GUDID 00844505000321

PARTIAL TILT TOP 3MM HEAD CENTERED 1.12MM ID DIA X 6MM L HA/OTOSIL

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505000321
• NIH Device Record Key: f6be0195-c704-4241-8c7a-c757ed08c0d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PARTIAL TILT TOP 3MM HEAD CENTERED
• Version Model Number: 250
• 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	00844505000321 [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

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• 10844505014080 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 10 PACK
• 10108445050141 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 10 PACK
• 10844505014165 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 30 PACK
• 10844505014189 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 30 PACK