TRULOAD (TM) SCREW DELIVERY SYSTEM 91-4004

GUDID 00841036164126

BIOMET MICROFIXATION, INC

Orthopaedic bone screw, non-bioabsorbable, non-sterile Orthopaedic bone screw, non-bioabsorbable, non-sterile

• Primary Device ID: 00841036164126
• NIH Device Record Key: f2141054-4815-4958-be4f-66368f5a6e3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TRULOAD (TM) SCREW DELIVERY SYSTEM
• Version Model Number: 91-4004
• Catalog Number: 91-4004
• Company DUNS: 046189866
• Company Name: BIOMET MICROFIXATION, INC
• 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: true
• 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(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM
• Phone: +1(904)741-4400
• Email: FXJAX-ORDERS@ZIMMERBIOMET.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841036164126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121589

FDA Product Code

• GXR: COVER, BURR HOLE

Sterilization

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

[00841036164126]

Moist Heat or Steam Sterilization

[00841036164126]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-11

On-Brand Devices [TRULOAD (TM) SCREW DELIVERY SYSTEM]

• 00841036164126: 91-4004
• 00841036164119: 91-3004
• 00841036162153: 15-4101