UNIV NAV HANDLE ROSAS00187

GUDID 03760244033628

"UNIVERSAL NAVIGATION HANDLE instrument Rosa one 3.1 (spine application) Handle for navigation of neurosurgical instruments"

MEDTECH

Multi-purpose stereotactic surgery system

• Primary Device ID: 03760244033628
• NIH Device Record Key: 6614e874-cd8d-42f0-881d-c24911371150
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIV NAV HANDLE
• Version Model Number: 174066-01
• Catalog Number: ROSAS00187
• Company DUNS: 264502977
• Company Name: MEDTECH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	03760244033628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182848

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

[03760244033628]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-06-08

On-Brand Devices [UNIV NAV HANDLE]

• 03760244033628: "UNIVERSAL NAVIGATION HANDLE instrument Rosa one 3.1 (spine application) Handle for navigation o
• 03760244031945: "UNIVERSAL NAVIGATION HANDLE instrument Rosa one 3.1 (spine application) Handle for navigation o