BEST PAK Access Needle PK1001

GUDID 00853508002218

Pedicle Access Needle PAK Bevel/Bevel

Lacey Manufacturing Company, LLC

Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula

• Primary Device ID: 00853508002218
• NIH Device Record Key: 269a34d4-13c0-4907-8887-ea5acd60ec87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEST PAK Access Needle
• Version Model Number: PK1001
• Catalog Number: PK1001
• 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	00853508002218 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

Radiation Sterilization

[00853508002218]

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