LIPPY BUCKET HANDLE W/NOTCH

GUDID 00844505001427

LIPPY BUCKET HANDLE W/NOTCH 0.8MM DIA X 3.75MM L TITANIUM

Grace Medical, Inc.

Ossicular prosthesis, partial

• Primary Device ID: 00844505001427
• NIH Device Record Key: 5432af28-306c-4b3b-a37b-8c44461fc6ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIPPY BUCKET HANDLE W/NOTCH
• Version Model Number: 425-375
• 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	00844505001427 [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: 2017-11-21

On-Brand Devices [LIPPY BUCKET HANDLE W/NOTCH ]

• 00844505002387: LIPPY BUCKET HANDLE W/NOTCH 0.6MM DIA X 3.75MM L TITANIUM
• 00844505001472: LIPPY BUCKET HANDLE W/NOTCH 0.8MM DIA X 5.00MM L TITANIUM
• 00844505001458: LIPPY BUCKET HANDLE W/NOTCH 0.8MM DIA X 4.50MM L TITANIUM
• 00844505001441: LIPPY BUCKET HANDLE W/NOTCH 0.8MM DIA X 4.25MM L TITANIUM
• 00844505001434: LIPPY BUCKET HANDLE W/NOTCH 0.8MM DIA X 4.00MM L TITANIUM
• 00844505001427: LIPPY BUCKET HANDLE W/NOTCH 0.8MM DIA X 3.75MM L TITANIUM
• 00844505001366: LIPPY BUCKET HANDLE W/NOTCH 0.6MM DIA X 5.00MM L TITANIUM
• 00844505001359: LIPPY BUCKET HANDLE W/NOTCH 0.6MM DIA X 4.75MM L TITANIUM
• 00844505001342: LIPPY BUCKET HANDLE W/NOTCH 0.6MM DIA X 4.50MM L TITANIUM
• 00844505001335: LIPPY BUCKET HANDLE W/NOTCH 0.6MM DIA X 4.25MM L TITANIUM
• 00844505001328: LIPPY BUCKET HANDLE W/NOTCH 0.6MM DIA X 4.00MM L TITANIUM
• 00844505001311: LIPPY BUCKET HANDLE W/NOTCH 0.6MM DIA X 3.50MM L TITANIUM
• 00844505001236: LIPPY BUCKET HANDLE W/NOTCH 0.4MM DIA X 5.00MM L TITANIUM
• 00844505001229: LIPPY BUCKET HANDLE W/NOTCH 0.4MM DIA X 4.75MM L TITANIUM
• 00844505001212: LIPPY BUCKET HANDLE W/NOTCH 0.4MM DIA X 4.50MM L TITANIUM
• 00844505001205: LIPPY BUCKET HANDLE W/NOTCH 0.4MM DIA X 4.25MM L TITANIUM
• 00844505001199: LIPPY BUCKET HANDLE W/NOTCH 0.4MM DIA X 4.00MM L TITANIUM
• 00844505001182: LIPPY BUCKET HANDLE W/NOTCH 0.4MM DIA X 3.75MM L TITANIUM
• 00844505001175: LIPPY BUCKET HANDLE W/NOTCH 0.4MM DIA X 3.50MM L TITANIUM