JuggerKnot Soft Anchor SSI003404

GUDID 00880304858954

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00880304858954
• NIH Device Record Key: 20b4eddc-26b8-4ae6-a10c-afde102e5989
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JuggerKnot Soft Anchor
• Version Model Number: SSI003404
• Catalog Number: SSI003404
• 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)348-9500
• Email: customerservice@zimmerbiomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304858954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150768

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[00880304858954]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2017-02-16

On-Brand Devices [JuggerKnot Soft Anchor]

• 00880304858985: SSI002542
• 00880304858978: SSI002297
• 00880304858961: SSI003405
• 00880304858954: SSI003404