ECLIPSE MALLEUS PISTON

GUDID 00844505010221

ECLIPSE MALLEUS PISTON 0.4MM DIA X 7.00MM L NITINOL/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505010221
• NIH Device Record Key: 8bb897b2-5e23-439f-85f0-0e2aeb745435
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECLIPSE MALLEUS PISTON
• Version Model Number: 440-700
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505010221 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-21

On-Brand Devices [ECLIPSE MALLEUS PISTON]

• 00844505010238: ECLIPSE MALLEUS PISTON 0.4MM DIA X 8.00MM L NITINOL/FLUOROPLASTIC
• 00844505010221: ECLIPSE MALLEUS PISTON 0.4MM DIA X 7.00MM L NITINOL/FLUOROPLASTIC
• 00844505010214: ECLIPSE MALLEUS PISTON 0.4MM DIA X 6.50MM L NITINOL/FLUOROPLASTIC
• 00844505010207: ECLIPSE MALLEUS PISTON 0.4MM DIA X 6.00MM L NITINOL/FLUOROPLASTIC
• 00844505010191: ECLIPSE MALLEUS PISTON 0.4MM DIA X 5.50MM L NITINOL/FLUOROPLASTIC
• 00844505006521: ECLIPSE MALLEUS PISTON 0.6MM DIA X 8.00MM L NITINOL/FLUOROPLASTIC
• 00844505006514: ECLIPSE MALLEUS PISTON 0.6MM DIA X 7.00MM L NITINOL/FLUOROPLASTIC
• 00844505006507: ECLIPSE MALLEUS PISTON 0.6MM DIA X 6.50MM L NITINOL/FLUOROPLASTIC
• 00844505006491: ECLIPSE MALLEUS PISTON 0.6MM DIA X 6.00MM L NITINOL/FLUOROPLASTIC
• 00844505006484: ECLIPSE MALLEUS PISTON 0.6MM DIA X 5.50MM L NITINOL/FLUOROPLASTIC