3i T3®

GUDID 00844868033301

3I T3® EX HEX TAPERED IMPLANT 5 X 10MM

BIOMET 3I, LLC

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• Primary Device ID: 00844868033301
• NIH Device Record Key: b1a977c8-f0c9-4223-aaaa-11bb4ddd9ab8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3i T3®
• Version Model Number: BOET510
• Company DUNS: 186127825
• Company Name: BIOMET 3I, LLC
• Device Count: 1
• DM Exempt: false
• 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(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com

Device Dimensions

• Length: 10 Millimeter
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844868033301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133049

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

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: 2018-07-06
• Device Publish Date: 2015-09-01

On-Brand Devices [3i T3®]

• 00844868033394: 3I T3® EX HEX TAPERED IMPLANT 6 X 8.5MM
• 00844868033387: 3I T3® EX HEX TAPERED IMPLANT 6 X 15MM
• 00844868033370: 3I T3® EX HEX TAPERED IMPLANT 6 X 13MM
• 00844868033363: 3I T3® EX HEX TAPERED IMPLANT 6 X 11.5MM
• 00844868033356: 3I T3® EX HEX TAPERED IMPLANT 6 X 10MM
• 00844868033349: 3I T3® EX HEX TAPERED IMPLANT 5 X 8.5MM
• 00844868033332: 3I T3® EX HEX TAPERED IMPLANT 5 X 15MM
• 00844868033325: 3I T3® EX HEX TAPERED IMPLANT 5 X 13MM
• 00844868033318: 3I T3® EX HEX TAPERED IMPLANT 5 X 11.5MM
• 00844868033301: 3I T3® EX HEX TAPERED IMPLANT 5 X 10MM
• 00844868033295: 3I T3® EX HEX TAPERED IMPLANT 4 X 8.5MM
• 00844868033288: 3I T3® EX HEX TAPERED IMPLANT 4 X 15MM
• 00844868033271: 3I T3® EX HEX TAPERED IMPLANT 4 X 13MM
• 00844868033264: 3I T3® EX HEX TAPERED IMPLANT 4 X 11.5MM
• 00844868033257: 3I T3® EX HEX TAPERED IMPLANT 4 X 10MM
• 00844868033240: 3I T3® EX HEX TAPERED IMPLANT 3.25 X 8.5MM
• 00844868033233: 3I T3® EX HEX TAPERED IMPLANT 3.25 X 15MM
• 00844868033226: 3I T3® EX HEX TAPERED IMPLANT 3.25 X 13MM
• 00844868033219: 3I T3® EX HEXTAPERED IMPLANT 3.25 X 11.5MM
• 00844868033202: 3I T3® EX HEX TAPERED IMPLANT 3.25 X 10MM
• 00844868032649: 3I T3® EX HEX PARALLEL WALLED IMPLANT 6 X 8.5MM
• 00844868032632: 3I T3® EX HEX PARALLEL WALLED IMPLANT 6 X 6.5MM
• 00844868032625: 3I T3® EX HEX PARALLEL WALLED IMPLANT 6 X 18MM
• 00844868032618: 3I T3® EX HEX PARALLEL WALLED IMPLANT 6 X 15MM
• 00844868032601: 3I T3® EX HEX PARALLEL WALLED IMPLANT 6 X 13MM
• 00844868032595: 3I T3® EX HEX PARALLEL WALLED IMPLANT 6 X 11.5MM
• 00844868032588: 3I T3® EX HEX PARALLEL WALLED IMPLANT 6 X 10MM
• 00844868032571: 3I T3® EX HEX PARALLEL WALLED IMPLANT 5 X 8.5MM
• 00844868032564: 3I T3® EX HEX PARALLEL WALLED IMPLANT 5 X 6.5MM
• 00844868032557: 3I T3® EX HEX PARALLEL WALLED IMPLANT 5 X 18MM
• 00844868032540: 3I T3® EX HEX PARALLEL WALLED IMPLANT 5 X 15MM
• 00844868032533: 3I T3® EX HEX PARALLEL WALLED IMPLANT 5 X 13MM
• 00844868032526: 3I T3® EX HEX PARALLEL WALLED IMPLANT 5 X 11.5MM
• 00844868032519: 3I T3® EX HEX PARALLEL WALLED IMPLANT 5 X 10MM
• 00844868032502: 3I T3® EX HEX PARALLEL WALLED IMPLANT 4 X 8.5MM
• 00844868032496: 3I T3® EX HEX PARALLEL WALLED IMPLANT 4 X 6.5MM
• 00844868032489: 3I T3® EX HEX PARALLEL WALLED IMPLANT 4 X 18MM
• 00844868032472: 3I T3® EX HEX PARALLEL WALLED IMPLANT 4 X 15MM
• 00844868032465: 3I T3® EX HEX PARALLEL WALLED IMPLANT 4 X 13MM
• 00844868032458: 3I T3® EX HEX PARALLEL WALLED IMPLANT 4 X 11.5MM
• 00844868032441: 3I T3® EX HEX PARALLEL WALLED IMPLANT 4 X 10MM
• 00844868032434: 3I T3® EX HEX PARALLEL WALLED IMPLANT 3.25 X 8.5MM
• 00844868032427: 3I T3® EX HEX PARALLEL WALLED IMPLANT 3.75 X 8.5MM
• 00844868032410: 3I T3® EX HEX PARALLEL WALLED IMPLANT 3.75 X 6.5MM
• 00844868032403: 3I T3® EX HEX PARALLEL WALLED IMPLANT 3.75 X 18MM
• 00844868032397: 3I T3® EX HEX PARALLEL WALLED IMPLANT 3.75 X 15MM
• 00844868032380: 3I T3® EX HEX PARALLEL WALLED IMPLANT 3.75 X 13MM
• 00844868032373: 3I T3® EX HEX PARALLEL WALLED IMPLANT 3.75 X 11.5MM
• 00844868032366: 3I T3® EX HEX PARALLEL WALLED IMPLANT 3.75 X 10MM
• 00844868032359: 3I T3® EX HEX PARALLEL WALLED IMPLANT 3.25 X 6.5MM