ENDOSCOPY INSTRUMENT ADAPTOR Ø 7 mm

FDA UDI

Class II (US FDA UDI)

by Medtech Llc

Identity

Trade Name: ENDOSCOPY INSTRUMENT ADAPTOR Ø 7 mm FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: Instrument Adaptor Ø7.0mm instrument Rosa One 3.1 (brain application) Ventricular endoscopy instrument adaptor to accomodate ventricular endoscopy instrument holder. Not for drilling" FDA UDI
Model / Reference: 174052-00 FDA UDI
Description: Instrument Adaptor Ø7.0mm instrument Rosa One 3.1 (brain application) Ventricular endoscopy instrument adaptor to accomodate ventricular endoscopy instrument holder. Not for drilling" FDA UDI

Identifiers

Catalog Number: ROSAS00332 FDA UDI
Primary DI / UDI-DI: 03760244032065 FDA UDI
FDA Product Code: HAW FDA UDI
GMDN Term: Multi-purpose stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

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Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

FDA UDI

Serial Number

Yes

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Expiration Date

FDA UDI

Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Multi-purpose stereotactic surgery system

The ENDOSCOPY INSTRUMENT ADAPTOR Ø 7 mm is a highly versatile and advanced instrument designed for precise positioning of medical devices during complex surgical procedures. This multi-purpose stereotactic surgery system features a rigid frame, workstation, and calibrated guide mechanism, allowing for accurate alignment of instruments and implants. The device also includes computerized functions to store diagnostic images used for image-guided surgery, making it an ideal solution for neurology and ENT applications.

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medtech Llc

Sources (1)

FDA UDI 4bfabecb-c41c-4a73-8e29-7316df7ffbe4 35 fields · synced Jul 18, 2026