Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012434811

FEI Number

3012434811

Entity Name

MEDICAL INSTRUMENTS S.P.A.

City/State/Country

San Lazzaro di Savena Bologna, IT

Establishment Address

Via Salarolo 2/B, San Lazzaro di Savena Bologna 40068, IT

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MEDICAL INSTRUMENTS S.p.A. (Owner Number: 10050802)

Owner / Operator Contact Address

Via Salarolo 2/B, San Lazzaro di Savena, IT-BO 40068, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

COLLAR The Snake suture organizer guide

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2020-10-21
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-12-29

Official Correspondent

No official correspondent registered.

US Agent Details

jay mansour Business: Mansour Consulting LLC Email: jay@mansourconsulting.com Phone: (678) 9088180

Related Public Records

Same Entity

MEDICAL INSTRUMENTS S.p.A.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012434811. Last updated year: 2026. Please use registration number 3012434811 when referencing this establishment in official correspondence.