Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003866267

FEI Number

3003866267

Entity Name

MARIAN MONTICELLO

City/State/Country

MONTICELLO, IN, US

Establishment Address

2787 SOUTH FREEMAN RD., MONTICELLO, IN 47960, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MARIAN MONTICELLO (Owner Number: 9053454)

Owner / Operator Contact Address

2787 SOUTH FREEMAN RD., --, Monticello, IN 47960, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2013-08-26
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-05-24
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2011-10-31
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2020-01-15
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2019-10-30

Official Correspondent

SARAH KUNDRAT

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MARIAN MONTICELLO

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

Similar Registrations

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3008646686	KIKGEL	Ujazd Opolskie, PL
8043484	Smith & Nephew Medical Ltd	HULL East Riding of Yorkshire, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003866267. Last updated year: 2026. Please use registration number 3003866267 when referencing this establishment in official correspondence.