STRAIGHT EXACT BROACH HANDLE 86-555500

GUDID 00880304461413

Biomet Orthopedics, LLC

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00880304461413
• NIH Device Record Key: ff50ec1c-5dd1-4d9f-896d-d8caa3f16555
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRAIGHT EXACT BROACH HANDLE
• Version Model Number: 86-555500
• Catalog Number: 86-555500
• 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: true
• 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	00880304461413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060121

FDA Product Code

• HAW: Neurological stereotaxic Instrument

Sterilization

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

[00880304461413]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2017-07-28

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