Unitrax 6942-5-058

GUDID 07613327032529

Head Component

Howmedica Osteonics Corp.

Uncoated hip femur prosthesis, one-piece

• Primary Device ID: 07613327032529
• NIH Device Record Key: d85aeab2-3452-4b90-b427-2f41db3bbfc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unitrax
• Version Model Number: 6942-5-058
• Catalog Number: 6942-5-058
• Company DUNS: 058311945
• Company Name: Howmedica Osteonics Corp.
• 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

Device Dimensions

• Outer Diameter: 58 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327032529 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014226

FDA Product Code

• KWL: Prosthesis, hip, hemi-, femoral, metal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Unitrax]

• 07613327032529: Head Component
• 07613327032512: Head Component
• 07613327032505: Head Component
• 07613327032499: Head Component
• 07613327032482: Head Component
• 07613327032475: Head Component
• 07613327032468: Head Component
• 07613327032451: Head Component
• 07613327032444: Head Component
• 07613327032437: Head Component
• 07613327032420: Head Component
• 07613327032413: Head Component
• 07613327032406: Head Component
• 07613327032390: Head Component
• 07613327032383: Head Component
• 07613327032376: Head Component
• 07613327032369: Head Component
• 07613327032352: Head Component
• 07613327032345: Head Component
• 07613327032338: Head Component
• 07613327013481: Neck Adjustment Sleeve
• 07613327013474: Neck Adjustment Sleeve
• 07613327013467: Neck Adjustment Sleeve
• 07613327013450: Neck Adjustment Sleeve
• 07613327013443: Neck Adjustment Sleeve
• 07613327013436: Neck Adjustment Sleeve
• 07613327013429: Neck Adjustment Sleeve
• 07613327013412: Neck Adjustment Sleeve
• 07613327013405: Neck Adjustment Sleeve
• 07613327013399: Neck Adjustment Sleeve
• 07613327013382: Neck Adjustment Sleeve
• 07613327013375: Neck Adjustment Sleeve
• 07613327013368: Neck Adjustment Sleeve