SUPER E PISTON

GUDID 00844505001793

SUPER E PISTON 0.5MM DIA X 3.75MM L NITINOL/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505001793
• NIH Device Record Key: cf79419a-f67e-4b37-b48f-05d35eb3d38b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPER E PISTON
• Version Model Number: 465-375
• 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	00844505001793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063374

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: 2020-05-11
• Device Publish Date: 2016-02-18

On-Brand Devices [SUPER E PISTON]

• 00844505001908: SUPER E PISTON 0.6MM DIA X 5.00MM L NITINOL/FLUOROPLASTIC
• 00844505001892: SUPER E PISTON 0.6MM DIA X 4.75MM L NITINOL/FLUOROPLASTIC
• 00844505001885: SUPER E PISTON 0.6MM DIA X 4.50MM L NITINOL/FLUOROPLASTIC
• 00844505001878: SUPER E PISTON 0.6MM DIA X 4.25MM L NITINOL/FLUOROPLASTIC
• 00844505001861: SUPER E PISTON 0.6MM DIA X 4.00MM L NITINOL/FLUOROPLASTIC
• 00844505001854: SUPER E PISTON 0.6MM DIA X 3.75MM L NITINOL/FLUOROPLASTIC
• 00844505001847: SUPER E PISTON 0.5MM DIA X 5.00MM L NITINOL/FLUOROPLASTIC
• 00844505001830: SUPER E PISTON 0.5MM DIA X 4.75MM L NITINOL/FLUOROPLASTIC
• 00844505001823: SUPER E PISTON 0.5MM DIA X 4.50MM L NITINOL/FLUOROPLASTIC
• 00844505001816: SUPER E PISTON 0.5MM DIA X 4.25MM L NITINOL/FLUOROPLASTIC
• 00844505001809: SUPER E PISTON 0.5MM DIA X 4.00MM L NITINOL/FLUOROPLASTIC
• 00844505001793: SUPER E PISTON 0.5MM DIA X 3.75MM L NITINOL/FLUOROPLASTIC