SurePass CTR NS Guide

GUDID 00860011634829

Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Guide

Dev4

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 00860011634829
• NIH Device Record Key: cdcd04fb-6ed7-4fbc-829b-d3bf5c306ae0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurePass CTR NS Guide
• Version Model Number: CT-2000NS
• Company DUNS: 119211016
• Company Name: Dev4
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011634829 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

[00860011634829]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-28
• Device Publish Date: 2025-05-20

Devices Manufactured by Dev4

• 00860011634829 - SurePass CTR NS Guide: 2025-05-28Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Guide
• 00860011634829 - SurePass CTR NS Guide: 2025-05-28 Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Guide
• 00860011634836 - SurePass CTR NS Blade: 2025-05-28 Carpal Tunnel Release, (1) SurePass CTR Non-Sterile Blade