ULTRA-DRIVE TOOL 423883

GUDID 00880304009905

Biomet Orthopedics, LLC

Hard-tissue ultrasonic surgical system handpiece tip

• Primary Device ID: 00880304009905
• NIH Device Record Key: c4238da9-f06d-44da-8e62-138d44057a11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRA-DRIVE TOOL
• Version Model Number: 423883
• Catalog Number: 423883
• 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: 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	00880304009905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031280

FDA Product Code

• JXE: DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-02-05
• Device Publish Date: 2016-09-22

On-Brand Devices [ULTRA-DRIVE TOOL]

• 00880304373099: 13MM HELICAL DRIVE
• 00880304373082: 11MM HELICAL DRIVE
• 00880304373075: 423923
• 00880304373068: 5.0 MM HELICAL DRIVE
• 00880304373051: 423881
• 00880304373020: 8 MM GOUGE
• 00880304372979: 5 MM HOE
• 00880304372931: 423837
• 00880304372894: 7 DEGREE 180 MM MALE/FEMALE
• 00880304372887: 5 DEGREE 180 MM MALE/FEMALE
• 00880304372870: 3 DEGREE 180 MM MALE/FEMALE
• 00880304009905: 423883
• 00880304008380: 7 MM, LONG POROUS GOUGE
• 00880304006683: 423819
• 00880304005563: 6MM PLUG PULLER
• 00880304005549: 6 MM, LONG CURVED OSTEOTOME
• 00880304005525: 9.5MM HELICAL DRIVE
• 00880304004887: 120 MM TIP EXTENDER
• 00880304004009: 9.5 MM DISK DRILL
• 00880304003316: 180 MM TIP EXTENDER
• 00880304003309: 180 MM MALE/FEMALE EXTENDER
• 00880304001855: 423873
• 00880304000933: 4MM HELICAL DRIVE
• 00880304000711: 6 MM LONG STRAIGHT OSTEOTOME
• 00880304000704: 60 MM TIP EXTENDER
• 00880304000698: 56 MM X 85 DEGREE ACETABULAR GOUGE
• 00880304000469: 5 MM REVERSE CURETTE
• 00880304000452: 7MM DISK DRILL
• 00880304000247: 9.5 MM SHORT OSTEOTOME