Biocore9 Humeral Resurfacing System 02-03-0044

GUDID 00810068850017

Biocore9 Humeral Head Resurfacing Shoulder Component 44 mm

Biocore9, LLC

Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis Resurfacing humeral head prosthesis

• Primary Device ID: 00810068850017
• NIH Device Record Key: fa8f1ce1-3a72-47dc-b4f1-67657dc4a096
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biocore9 Humeral Resurfacing System
• Version Model Number: Humeral Resurfacing Component 44 mm
• Catalog Number: 02-03-0044
• 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	00810068850017 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193122

FDA Product Code

• HSD: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

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: 2021-10-06
• Device Publish Date: 2021-09-28

On-Brand Devices [Biocore9 Humeral Resurfacing System]

• 00810068850048: Biocore9 Humeral Head Resurfacing Shoulder Component 56 mm
• 00810068850031: Biocore9 Humeral Head Resurfacing Shoulder Component 52 mm
• 00810068850024: Biocore9 Humeral Head Resurfacing Shoulder Component 48 mm
• 00810068850017: Biocore9 Humeral Head Resurfacing Shoulder Component 44 mm