GRACE MEDICAL FLUOROPLASTIC PISTON

GUDID 00844505000529

FLUOROPLASTIC PISTON 0.4MM DIA X 5.00MM L

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505000529
• NIH Device Record Key: 60165340-ed64-4338-864e-e8cee4fa321f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRACE MEDICAL FLUOROPLASTIC PISTON
• Version Model Number: 401-500
• 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	00844505000529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060518

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: 2020-04-27
• Device Publish Date: 2016-02-18

On-Brand Devices [GRACE MEDICAL FLUOROPLASTIC PISTON]

• 00844505000758: FLUOROPLASTIC PISTON 0.5MM DIA X 6.00MM L
• 00844505000741: FLUOROPLASTIC PISTON 0.5MM DIA X 5.00MM L
• 00844505000734: FLUOROPLASTIC PISTON 0.5MM DIA X 4.50MM L
• 00844505000727: FLUOROPLASTIC PISTON ARRIGG SLIT MOD 0.4MM DIA x 6.00MM L
• 00844505000710: FLUOROPLASTIC PISTON ARRIGG SLIT MOD 0.4MM DIA x 4.50MM L
• 00844505000703: FLUOROPLASTIC PISTON ARRIGG SLIT MOD 0.4MM DIA x 4.25MM L
• 00844505000635: FLUOROPLASTIC PISTON 0.8MM DIA X 6.00MM L
• 00844505000628: FLUOROPLASTIC PISTON 0.8MM DIA X 5.00MM L
• 00844505000611: FLUOROPLASTIC PISTON 0.8MM DIA X 4.50MM L
• 00844505000604: FLUOROPLASTIC PISTON 0.8MM DIA X 4.00MM L
• 00844505000598: FLUOROPLASTIC PISTON 0.8MM DIA X 3.50MM L
• 00844505000581: FLUOROPLASTIC PISTON 0.6MM DIA X 6.00MM L
• 00844505000574: FLUOROPLASTIC PISTON 0.6MM DIA X 5.00MM L
• 00844505000567: FLUOROPLASTIC PISTON 0.6MM DIA X 4.50MM L
• 00844505000550: FLUOROPLASTIC PISTON 0.6MM DIA X 4.00MM L
• 00844505000543: FLUOROPLASTIC PISTON 0.6MM DIA X 3.50MM L
• 00844505000536: FLUOROPLASTIC PISTON 0.4MM DIA X 6.00MM L
• 00844505000529: FLUOROPLASTIC PISTON 0.4MM DIA X 5.00MM L
• 00844505000512: FLUOROPLASTIC PISTON 0.4MM DIA X 4.50MM L
• 00844505000505: FLUOROPLASTIC PISTON 0.4MM DIA X 4.00MM L
• 00844505000499: FLUOROPLASTIC PISTON 0.4MM DIA X 3.50MM L