Biocore9 Femoral Resurfacing Component 01-03-0044

GUDID 00810068850413

Biocore9 Femoral Resurfacing Head Component 44 mm

Biocore9, LLC

Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis Resurfacing metallic femoral head prosthesis

• Primary Device ID: 00810068850413
• NIH Device Record Key: 9dad2720-397e-45b8-88ab-4253fc88c3e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biocore9 Femoral Resurfacing Component
• Version Model Number: Femoral Resurfacing Component - 44 mm
• Catalog Number: 01-03-0044
• Company DUNS: 093081548
• Company Name: Biocore9, 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: true
• 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

Device Dimensions

• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter
• Outer Diameter: 44 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810068850413 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201219

FDA Product Code

• KXA: Prosthesis, Hip, Femoral, Resurfacing

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-05
• Device Publish Date: 2021-09-27

On-Brand Devices [Biocore9 Femoral Resurfacing Component]

• 00810068850468: Biocore9 Femoral Resurfacing Head Component 52.5 mm
• 00810068850451: Biocore9 Femoral Resurfacing Head Component 51 mm
• 00810068850444: Biocore9 Femoral Resurfacing Head Component 49 mm
• 00810068850437: Biocore9 Femoral Resurfacing Head Component 47 mm
• 00810068850420: Biocore9 Femoral Resurfacing Head Component 45.5 mm
• 00810068850413: Biocore9 Femoral Resurfacing Head Component 44 mm
• 00810068850406: Biocore9 Femoral Resurfacing Head Component 42.5 mm
• 00810068850390: Biocore9 Femoral Resurfacing Head Component 41 mm
• 00810068850383: Biocore9 Femoral Resurfacing Head Component 39.5 mm