Trnsnsl Endscp Ovoid Ø6.18mm Holder

Basic Information

• Brand Name: Trnsnsl Endscp Ovoid Ø6.18mm Holder
• Primary DI: 03760244031129
• Version / Model: 174008-00
• Catalog Number: ROSAS00318
• Company Name: MEDTECH
• Labeler DUNS: 264502977
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-27
• Public Version: 1
• Public Version Date: 2023-11-06
• Public Version Status: New
• Public Device Record Key: bd0fcf0c-d2ef-4112-94ef-e31063353f45

Device Description

Trnsnsl Endscp Ovoid Ø6.18mm Holder instrument Rosa 3.1 (Brain application) instrument holder for guidance of a Storz sheath 7230 AS-AES during endonasal procedures, positioned by the robot arm in accordance with pre- operative plan

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HAW	Neurological Stereotaxic Instrument	Neurology	882.4560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45199	Multi-purpose stereotactic surgery system	An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03760244031129	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K231103	000