NO-PROFILE 904545

GUDID 00880304406001

Biomet Sports Medicine, LLC

Ligament bone anchor

• Primary Device ID: 00880304406001
• NIH Device Record Key: ceccb032-1905-4ea5-95d7-76c8f49302d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NO-PROFILE
• Version Model Number: 904545
• Catalog Number: 904545
• Company DUNS: 627100159
• Company Name: Biomet Sports Medicine, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00880304406001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981967

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2015-10-24

On-Brand Devices [NO-PROFILE]

• 00880304406155: 904648
• 00880304406148: 904646
• 00880304406131: 904644
• 00880304406124: 904642
• 00880304406117: 904640
• 00880304406100: 904638
• 00880304406094: 904636
• 00880304406087: 904634
• 00880304406070: 904632
• 00880304406063: 904630
• 00880304406056: 904570
• 00880304406049: 904565
• 00880304406032: 904560
• 00880304406025: 904555
• 00880304406018: 904550
• 00880304406001: 904545
• 00880304405998: 904540
• 00880304405981: 904535
• 00880304405974: 904530
• 00880304405776: 904428