UNIFLEX SYSTEM 33-345542

GUDID 00880304352650

Biomet Orthopedics, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 00880304352650
• NIH Device Record Key: 1a3a36f9-7481-4cc7-85bf-5a54c802132a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIFLEX SYSTEM
• Version Model Number: 33-345542
• Catalog Number: 33-345542
• 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: 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)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
• 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
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00880304352650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982953

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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: 2015-10-24

On-Brand Devices [UNIFLEX SYSTEM]

• 00880304529823: 344265
• 00880304529816: 344380
• 00880304529809: 344075
• 00880304529793: 344375
• 00880304529786: 344170
• 00880304529144: 344365
• 00880304529137: 344165
• 00880304523487: 344065
• 00880304522169: 344070
• 00880304522091: 344275
• 00880304521773: 344470
• 00880304516052: 344060
• 00880304511613: 344270
• 00880304511316: 344160
• 00880304511279: 344480
• 00880304507845: 344280
• 00880304507708: 344465
• 00880304507692: 344370
• 00880304491205: 344175
• 00880304489516: 344475
• 00880304357594: 345296
• 00880304357587: 345294
• 00880304357280: 345211
• 00880304352681: 33-345548
• 00880304352674: 33-345546
• 00880304352667: 33-345544
• 00880304352650: 33-345542
• 00880304352643: 33-345540
• 00880304352629: 33-345538
• 00880304352612: 33-345536
• 00880304352605: 33-345534
• 00880304352582: 33-345532
• 00880304352575: 33-345530
• 00880304352568: 33-345528
• 00880304352544: 33-345526
• 00880304352520: 33-345524
• 00880304352506: 33-345522
• 00880304352483: 33-345520
• 00888480285588: 344180
• 00888480285434: 344080