ROBINSON BUCKET HANDLE

GUDID 00844505001380

ROBINSON BUCKET HANDLE 0.8MM DIA X 4.25MM L TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505001380
• NIH Device Record Key: cc791b6b-756a-4b14-b23d-e75ddc8fdd47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROBINSON BUCKET HANDLE
• Version Model Number: 424-425
• 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	00844505001380 [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 [ROBINSON BUCKET HANDLE]

• 00844505001403: ROBINSON BUCKET HANDLE 0.8MM DIA X 5.00MM L TITANIUM
• 00844505001397: ROBINSON BUCKET HANDLE 0.8MM DIA X 4.50MM L TITANIUM
• 00844505001380: ROBINSON BUCKET HANDLE 0.8MM DIA X 4.25MM L TITANIUM
• 00844505001373: ROBINSON BUCKET HANDLE 0.8MM DIA X 4.00MM L TITANIUM
• 00844505001304: ROBINSON BUCKET HANDLE 0.6MM DIA X 5.00MM L TITANIUM
• 00844505001298: ROBINSON BUCKET HANDLE 0.6MM DIA X 4.75MM L TITANIUM
• 00844505001281: ROBINSON BUCKET HANDLE 0.6MM DIA X 4.50MM L TITANIUM
• 00844505001274: ROBINSON BUCKET HANDLE 0.6MM DIA X 4.25MM L TITANIUM
• 00844505001267: ROBINSON BUCKET HANDLE 0.6MM DIA X 4.00MM L TITANIUM
• 00844505001250: ROBINSON BUCKET HANDLE 0.6MM DIA X 3.75MM L TITANIUM
• 00844505001243: ROBINSON BUCKET HANDLE 0.6MM DIA X 3.50MM L TITANIUM
• 00844505001168: ROBINSON BUCKET HANDLE 0.4MM DIA X 5.00MM L TITANIUM
• 00844505001151: ROBINSON BUCKET HANDLE 0.4MM DIA X 4.75MM L TITANIUM
• 00844505001144: ROBINSON BUCKET HANDLE 0.4MM DIA X 4.50MM L TITANIUM
• 00844505001137: ROBINSON BUCKET HANDLE 0.4MM DIA X 4.25MM L TITANIUM
• 00844505001120: ROBINSON BUCKET HANDLE 0.4MM DIA X 4.00MM L TITANIUM
• 00844505001113: ROBINSON BUCKET HANDLE 0.4MM DIA X 3.75MM L TITANIUM
• 00844505001106: ROBINSON BUCKET HANDLE 0.4MM DIA X 3.50MM L TITANIUM