JuggerKnotless Low Profile Guide SSI005542

GUDID 00889024583863

Biomet Orthopedics, LLC

Orthopaedic bone staple, non-adjustable, sterile

• Primary Device ID: 00889024583863
• NIH Device Record Key: e2de5574-e515-46df-8455-5b6c9efa2dc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JuggerKnotless Low Profile Guide
• Version Model Number: SSI005542
• Catalog Number: SSI005542
• 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: 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) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com
• Phone: 1 (800) 343-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024583863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123485

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

[00889024583863]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-14
• Device Publish Date: 2020-02-06

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• 08428898885691 - BIPASS DISPOSABLE PUSHER: 2024-09-11
• 00880304338548 - AGC ANTERIOR FILE: 2024-09-11
• 00880304339224 - PARALLEL PULLER: 2024-09-11
• 00880304342187 - AGC MODULAR TIBIAL II: 2024-09-11
• 00880304365247 - BIO-MODULAR: 2024-09-11