Biocore9 Femoral Resurfacing Component 01-03-0047

GUDID 00810068850437

Biocore9 Femoral Resurfacing Head Component 47 mm

Biocore9, LLC

Resurfacing metallic femoral head prosthesis

• Primary Device ID: 00810068850437
• NIH Device Record Key: 4a6e2d5b-f934-4e7d-b982-bb7581a8de11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biocore9 Femoral Resurfacing Component
• Version Model Number: Femoral Resurfacing Component - 47 mm
• Catalog Number: 01-03-0047
• 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: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 Millimeter
• Outer Diameter: 47 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	00810068850437 [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