JuggerKnot Soft Anchors 912084

GUDID 00880304523401

Biomet Orthopedics, LLC

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 00880304523401
• NIH Device Record Key: 391e4983-d2b1-4cd7-952a-febde95024fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JuggerKnot Soft Anchors
• Version Model Number: 912084
• Catalog Number: 912084
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304523401 [Primary]
GS1	70880304523400 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110879

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-18
• Device Publish Date: 2015-10-24

On-Brand Devices [JuggerKnot Soft Anchors]

• 00880304980204: SSI001657
• 00880304564015: 912074
• 00880304545861: 010000335
• 00880304545847: 010000334
• 00880304523418: 912082
• 00880304523401: 912084
• 00880304522114: 912529
• 00880304520950: 912080
• 00880304520820: 912076
• 00880304516762: 912060
• 00880304516557: 912015
• 00880304509641: 912068
• 00880304477209: 912010