FLUOROPLASTIC PISTON

GUDID 00844505009720

GRACE FLUOROPLASTIC PISTON W/O SLIT 0.4MM DIA. X 6.00MM L, 0.8MM ID FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505009720
• NIH Device Record Key: dd5deaf4-1806-450e-959b-fd3927e8dcce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLUOROPLASTIC PISTON
• Version Model Number: 436-600M
• Company DUNS: 030849173
• Company Name: Grace Medical, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00844505009720 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-02-18

On-Brand Devices [FLUOROPLASTIC PISTON]

• 00844505009720: GRACE FLUOROPLASTIC PISTON W/O SLIT 0.4MM DIA. X 6.00MM L, 0.8MM ID FLUOROPLASTIC
• 00844505009638: GRACE FLUOROPLASTIC PISTON 0.4MM DIA. X 6.00MM L, 0.8MM ID FLUOROPLASTIC
• 00844505008167: FLUOROPLASTIC PISTON 0.6MM DIA X 8.00MM L
• 00844505000482: FLUOROPLASTIC PISTON 0.3MM DIA X 6.00MM L
• 00844505000475: FLUOROPLASTIC PISTON 0.3MM DIA X 5.00MM L
• 00844505000468: FLUOROPLASTIC PISTON 0.3MM DIA X 4.50MM L