REUNITE SCREW SYSTEM 348846

GUDID 00880304420120

Biomet Orthopedics, LLC

Orthopaedic bone screw, bioabsorbable

• Primary Device ID: 00880304420120
• NIH Device Record Key: 6ab0a94b-1675-4c8c-b2d4-4673cc57ea6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REUNITE SCREW SYSTEM
• Version Model Number: 348846
• Catalog Number: 348846
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• 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 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 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 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 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	00880304420120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984390

FDA Product Code

• HWC: Screw, fixation, bone

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: 2018-10-17
• Device Publish Date: 2015-10-24

On-Brand Devices [REUNITE SCREW SYSTEM]

• 00880304424906: 948854
• 00880304424760: 948826
• 00880304424548: 948496
• 00880304424517: 948493
• 00880304424494: 948491
• 00880304420168: 348858
• 00880304420144: 348854
• 00880304420137: 348850
• 00880304420120: 348846
• 00880304420113: 348842
• 00880304420106: 348838
• 00880304420090: 348836
• 00880304420076: 348834
• 00880304420069: 348832
• 00880304420052: 348830
• 00880304420045: 348828
• 00880304420038: 348826
• 00880304420021: 348824
• 00880304420014: 348822
• 00880304420007: 348820
• 00880304419834: 348527
• 00880304419827: 348511
• 00880304419810: 348510
• 00880304419803: 348509
• 00880304419797: 348508
• 00880304419780: 348507
• 00880304419773: 348506
• 00880304419766: 348505
• 00880304419759: 348504
• 00880304419742: 348503
• 00880304419735: 348502
• 00880304419728: 348501
• 00880304419711: 348500
• 00880304419704: 348496
• 00880304419698: 348495
• 00880304419681: 348494
• 00880304419674: 348493
• 00880304419667: 348492
• 00880304419650: 348491
• 00880304419643: 348490
• 00880304419582: 348471
• 00880304419575: 348470
• 00880304419568: 348461
• 00880304419551: 348460
• 00880304419544: 348451
• 00880304419537: 348450
• 00880304419520: 348446
• 00880304419513: 348445
• 00880304419506: 348441
• 00880304419490: 348440