primaLOK-FF

GUDID 00813210022058

3mm Cannulated Drill

WENZEL SPINE, INC.

Fluted surgical drill bit, reusable

• Primary Device ID: 00813210022058
• NIH Device Record Key: 621ace1f-48e0-49fa-b675-80f1354e8c16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: primaLOK-FF
• Version Model Number: 800-1201
• Company DUNS: 832543255
• Company Name: WENZEL SPINE, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com
• Phone: 855-936-9351
• Email: info@wenzelspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813210022058 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

[00813210022058]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-31
• Device Publish Date: 2019-12-23

Devices Manufactured by WENZEL SPINE, INC.

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• 00813210020016 - VariLift-L: 2020-02-24 The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and
• 00813210020023 - VariLift-L: 2020-02-24 The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and
• 00813210020030 - VariLift-C: 2020-02-24 The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interi
• 00813210020047 - VariLift-C: 2020-02-24 The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interi
• 00813210020054 - VariLift-C: 2020-02-24 The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interi
• 00813210020061 - VariLift-C: 2020-02-24 The Wenzel Spine VariLift-C Cervical Interbody Fusion Device System consists of a self-tapping, expandable device with an interi
• 00813210020078 - VariLift-LX: 2020-02-24 The Wenzel Spine VariLift-LX Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a p