UNIVERSAL PROSTHESIS

GUDID 00844505000222

UNIVERSAL PROSTHESIS OTOSIL/HA, FIXED HEAD, TOTAL & PARTIAL SHAFTS SUPPLIED

Grace Medical, Inc.

Ossicular prosthesis, total

• Primary Device ID: 00844505000222
• NIH Device Record Key: 54769b35-9fc2-4d76-9196-2ade449820ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL PROSTHESIS
• Version Model Number: 193
• 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	00844505000222 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972815

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

Devices Manufactured by Grace Medical, Inc.

• 00844505014403 - ApollOS: 2024-05-13 ApollOS™
• 10844505014394 - TOUMA VENT TUBE W/ TAB: 2024-01-31 MODIFIED TOUMA VENT TUBE W/ TAB 1.27MM ID SILICONE
• 10844505014004 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID FLUOROPLASTIC 5 PACK
• 10844505014042 - ARMSTRONG VENT TUBE: 2023-12-12 ARMSTRONG VENT TUBE 1.14MM ID BLUE FLUOROPLASTIC 5 PACK
• 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