V40 6364-2-022

GUDID 07613327123852

V40 Femoral Head

Howmedica Osteonics Corp.

Metallic femoral head prosthesis

• Primary Device ID: 07613327123852
• NIH Device Record Key: 7848fe5c-19ec-4451-8470-9771f14e5091
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V40
• Version Model Number: 6364-2-022
• Catalog Number: 6364-2-022
• 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327123852 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173499

FDA Product Code

• JDI: Prosthesis, hip, semi-constrained, metal/polymer, cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-04-06
• Device Publish Date: 2018-06-13

On-Brand Devices [V40]

• 07613327124033: V40 Femoral Head
• 07613327123852: V40 Femoral Head