Biolox Delta Head 5010.42.403

GUDID 08033390046374

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

LIMACORPORATE SPA

Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis Ceramic femoral head prosthesis

• Primary Device ID: 08033390046374
• NIH Device Record Key: 71aaf208-ae33-426b-b6a7-5641f4ae58b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biolox Delta Head
• Version Model Number: 5010.42.403
• Catalog Number: 5010.42.403
• 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	08033390046374 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182099

FDA Product Code

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

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