Biolox Delta Head 5010.42.404

GUDID 08033390046381

Femoral Heads (Biolox®Delta) Dia. 40mm #XL

LIMACORPORATE SPA

Ceramic femoral head prosthesis

• Primary Device ID: 08033390046381
• NIH Device Record Key: 815124f0-0576-4d40-9124-296a7ba7518a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolox Delta Head
• Version Model Number: 5010.42.404
• Catalog Number: 5010.42.404
• Company DUNS: 432066322
• Company Name: LIMACORPORATE SPA
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390046381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182099

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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: 2020-09-09
• Device Publish Date: 2019-01-04

On-Brand Devices [Biolox Delta Head]

• 08033390046381: Femoral Heads (Biolox®Delta) Dia. 40mm #XL
• 08033390046374: Femoral Heads (Biolox®Delta) Dia. 40mm #L
• 08033390046367: Femoral Heads (Biolox®Delta) Dia. 40mm #M
• 08033390046350: Femoral Heads (Biolox®Delta) Dia. 40mm #S