ProCol Vascular Bioprosthesis

GUDID 00866271000022

Hancock Jaffe Laboratories, Inc.

Arteriovenous shunt

• Primary Device ID: 00866271000022
• NIH Device Record Key: f0077d81-dd85-413b-b8f4-ff47f83da195
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProCol Vascular Bioprosthesis
• Version Model Number: HJL016-30-N
• Company DUNS: 189530538
• Company Name: Hancock Jaffe Laboratories, Inc.
• 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: false
• Serial Number: true
• 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

Device Dimensions

• Lumen/Inner Diameter: 6 Millimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 30 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 30 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 30 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 30 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 30 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 30 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 30 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 30 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 30 Centimeter
• Lumen/Inner Diameter: 6 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866271000022 [Primary]

FDA Product Code

• LXA: Tissue Graft Of 6mm And Greater

Sterilization

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

[00866271000022]

Radiation Sterilization

[00866271000022]

Radiation Sterilization

[00866271000022]

Radiation Sterilization

[00866271000022]

Radiation Sterilization

[00866271000022]

Radiation Sterilization

[00866271000022]

Radiation Sterilization

[00866271000022]

Radiation Sterilization

[00866271000022]

Radiation Sterilization

[00866271000022]

Radiation Sterilization

[00866271000022]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-08-14

On-Brand Devices [ProCol Vascular Bioprosthesis]

• 00866271000039: HJL016-40-N
• 00866271000022: HJL016-30-N
• 00866271000015: HJL016-25-N
• 00866271000008: HJL016-10-N