HIPLOC SYSTEM 190103

GUDID 05019279410125

Biomet Uk Ltd

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 05019279410125
• NIH Device Record Key: 97e8e038-1418-472a-a231-f7fa90eb56cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIPLOC SYSTEM
• Version Model Number: 190103
• Catalog Number: 190103
• Company DUNS: 219322575
• Company Name: Biomet Uk Ltd
• 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.c
• Phone: +1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05019279410125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080685

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

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 [HIPLOC SYSTEM]

• 05019279424580: 236055
• 05019279410132: 190104
• 05019279410125: 190103
• 05019279410118: 190102
• 05019279410101: 190101
• 05019279410095: 190100