ECLIPSE MALLEUS PISTON MODIFIED LOOP

GUDID 00844505011136

ECLIPSE MALLEUS PISTON MODIFIED LOOP 0.6MM DIA X 8.00MM L NITINOL/FLUOROPLASTIC

Grace Medical, Inc.

Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial Ossicular prosthesis, partial

• Primary Device ID: 00844505011136
• NIH Device Record Key: 8369b0e1-75c9-4c4b-aa06-d7250f4fe77b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECLIPSE MALLEUS PISTON MODIFIED LOOP
• Version Model Number: 443-800
• 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: 866-472-2363
• Email: info@gracemedical.com
• Phone: 866-472-2363
• Email: info@gracemedical.com
• Phone: 866-472-2363
• Email: info@gracemedical.com
• Phone: 866-472-2363
• Email: info@gracemedical.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844505011136 [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: 2017-01-19

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