Universal Dilator 521-0002

GUDID M7405210002

Pedicle Markers

SPINEOLOGY INC.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: M7405210002
• NIH Device Record Key: 00b38aea-cfa4-419d-8d45-a8ab706440ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Dilator
• Version Model Number: 52-02-09
• Catalog Number: 521-0002
• Company DUNS: 033014361
• Company Name: SPINEOLOGY INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com
• Phone: 651-256-8500
• Email: info@spineology.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M7405210002 [Primary]

FDA Product Code

• LXN: Probe, Test, Heart-Valve

Sterilization

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

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

[M7405210002]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-27
• Device Publish Date: 2023-12-19

On-Brand Devices [Universal Dilator ]

• M7401001271: Snap Lock Ring
• M7401001270: Impact Cap Snap Lock
• M7405230012: Wrench
• M7405230004: Tightener
• M7405230003: Snap Clip
• M7405230002: Impact Cap
• M7405230001: Cannulated Dilator
• M7405210005: Non-Threaded, Double Ring
• M7405210004: Pedicle Markers
• M7405210003: Non- threaded, Single Ring
• M7405210002: Pedicle Markers
• M7405210001: Pedicle Marker Inserter