Biocore9 Humeral Resurfacing System 02-03-0052

GUDID 00810068850031

Biocore9 Humeral Head Resurfacing Shoulder Component 52 mm

Biocore9, LLC

Resurfacing humeral head prosthesis

• Primary Device ID: 00810068850031
• NIH Device Record Key: f5180a85-e20e-4e62-8f2a-d2c79a3f523f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biocore9 Humeral Resurfacing System
• Version Model Number: Humeral Resurfacing Component 52 mm
• Catalog Number: 02-03-0052
• 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: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 Millimeter
• Outer Diameter: 52 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	00810068850031 [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