BEST PAK Access Needle PK1005

GUDID 00853508002256

PAK Access Needle XPAK Trocar

Lacey Manufacturing Company, LLC

Bone access cannula

• Primary Device ID: 00853508002256
• NIH Device Record Key: a0c8e007-9917-4692-a457-fcd7873cc94f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEST PAK Access Needle
• Version Model Number: PK1005
• Catalog Number: PK1005
• Company DUNS: 958212029
• Company Name: Lacey Manufacturing Company, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com
• Phone: 203-336-7453
• Email: jim.rogers@paragonmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853508002256 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

[00853508002256]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-23
• Device Publish Date: 2023-06-15

On-Brand Devices [BEST PAK Access Needle ]

• 00853508002256: PAK Access Needle XPAK Trocar
• 00853508002249: PAK Pedicle Access Needle XPAK Bevel
• 00853508002232: PAK Pedicle Access Needle Trocar/Bevel
• 00853508002225: PAK Access Needle Trocar/Trocar
• 00853508002218: Pedicle Access Needle PAK Bevel/Bevel