ProCol Vascular Bioprosthesis

GUDID 00866271000008

Hancock Jaffe Laboratories, Inc.

Arteriovenous shunt Arteriovenous shunt Arteriovenous shunt Arteriovenous shunt Arteriovenous shunt Arteriovenous shunt Arteriovenous shunt Arteriovenous shunt Arteriovenous shunt Arteriovenous shunt Arteriovenous shunt

• Primary Device ID: 00866271000008
• NIH Device Record Key: 8ab140bd-427b-4ffc-adad-af1981befcc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProCol Vascular Bioprosthesis
• Version Model Number: HJL016-10-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: 10 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 10 Centimeter
• Lumen/Inner Diameter: 6 Millimeter
• Length: 10 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	00866271000008 [Primary]

FDA Product Code

• LXA: Tissue Graft Of 6mm And Greater

Sterilization

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

[00866271000008]

Radiation Sterilization

[00866271000008]

Radiation Sterilization

[00866271000008]

Radiation Sterilization

[00866271000008]

Radiation Sterilization

[00866271000008]

Radiation Sterilization

[00866271000008]

Radiation Sterilization

[00866271000008]

Radiation Sterilization

[00866271000008]

Radiation Sterilization

[00866271000008]

Radiation Sterilization

[00866271000008]

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