TAPERLOC COMPLETE 51-206130

GUDID 00880304516861

Biomet Orthopedics, LLC

Bone file/rasp, manual

• Primary Device ID: 00880304516861
• NIH Device Record Key: 3a866f73-9e5f-4100-9507-c315098b0490
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TAPERLOC COMPLETE
• Version Model Number: 51-206130
• Catalog Number: 51-206130
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304516861 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110400

FDA Product Code

• MEH: Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00880304516861]

Moist Heat or Steam Sterilization

[00880304516861]

Moist Heat or Steam Sterilization

[00880304516861]

Moist Heat or Steam Sterilization

[00880304516861]

Moist Heat or Steam Sterilization

[00880304516861]

Moist Heat or Steam Sterilization

[00880304516861]

Moist Heat or Steam Sterilization

[00880304516861]

Moist Heat or Steam Sterilization

[00880304516861]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-05-30
• Device Publish Date: 2016-09-22

On-Brand Devices [TAPERLOC COMPLETE]

• 00880304546004: 51-206220
• 00880304545991: 51-206240
• 00880304541337: 51-206200
• 00880304532120: 51-222225
• 00880304520776: 51-206180
• 00880304520769: 51-208040
• 00880304520141: 51-208080
• 00880304519718: 51-208070
• 00880304519701: 51-208050
• 00880304519695: 51-208060
• 00880304516861: 51-206130
• 00880304516854: 51-206100
• 00880304516847: 51-206140
• 00880304516830: 51-206120
• 00880304516823: 51-206160
• 00880304516816: 51-206090
• 00880304516809: 51-206110
• 00880304516793: 51-206170
• 00880304516786: 51-206150
• 00880304509726: 51-222223
• 00880304506787: 51-201040
• 00880304497085: 51-201060
• 00880304497078: 51-201050
• 00880304481046: 51-200000
• 00880304480964: 51-201070
• 00880304480957: 51-201080
• 00880304480940: 51-201170
• 00880304480926: 51-201150
• 00880304480902: 51-201120
• 00880304480896: 51-201130