VARISATION STAPLEØ 1,0MM P107

GUDID 00887868115691

Biomet Orthopedics, LLC

Orthopaedic bone staple, non-adjustable, non-sterile

• Primary Device ID: 00887868115691
• NIH Device Record Key: 754fa60a-8e21-43f9-b55a-c68cb888c5df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VARISATION STAPLEØ 1,0MM
• Version Model Number: P107
• Catalog Number: P107
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887868115691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931155

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00887868115691]

Moist Heat or Steam Sterilization

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 [VARISATION STAPLEØ 1,0MM]

• 00887868115714: P109
• 00887868115707: P108
• 00887868115691: P107
• 00887868115684: P106