Inst Rnd Peek Adp Ø7.0mm

FDA UDI

Class II (US FDA UDI)

by Medtech Llc

Identity

Trade Name: INST RND PEEK ADP Ø7.0MM FDA UDI
Generic Name: Multi-purpose stereotactic surgery system FDA UDI
Device Name: "PEEK INSTRUMENT ADAPTOR Ø7.0MM instrument Rosa One 3.1 (brain application) instrument adaptor designed for guidance of biopsy needles, stimulation or recording electrodes" FDA UDI
Model / Reference: 174092 FDA UDI
Description: "PEEK INSTRUMENT ADAPTOR Ø7.0MM instrument Rosa One 3.1 (brain application) instrument adaptor designed for guidance of biopsy needles, stimulation or recording electrodes" FDA UDI

Identifiers

Catalog Number: ROSAS00073 FDA UDI
Primary DI / UDI-DI: 03760244032461 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Multi-purpose stereotactic surgery system

Inst Rnd Peek Adp Ø7.0mm by Medtech Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 af1c24bd-c24b-4fad-8475-b0bc39163d49 34 fields · synced May 30, 2026