MedtechSourcebook

MARIAN MONTICELLO

Contract manufacturer · Monticello, IN

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
3003866267 (openFDA record; or search FDA's registration database)
FEI number
3003866267
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer; Repackager or relabeler
Owner or operator
MARIAN MONTICELLO (FDA owner/operator no. 9053454)
Registered address
2787 SOUTH FREEMAN RD., Monticello, IN 47960
Contract listings
6 device listings, 6 product codes, first listed Oct 31, 2011
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
CCXSupport, Patient PositionClass IAnesthesiologyContract manufacturingOct 30, 2019
GDTStaple, Removable (Skin)Class IGeneral and plastic surgeryContract manufacturingJan 15, 2020
KGXTape And Bandage, AdhesiveClass IGeneral hospitalContract manufacturingMay 24, 2017
MDAElastomer, Silicone, For Scar ManagementClass IGeneral and plastic surgeryContract manufacturingOct 31, 2011
MQXNeedle, Acupuncture, Single UseClass IIGeneral hospitalContract manufacturingMay 22, 2024
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicClass IGeneral and plastic surgeryContract manufacturingAug 26, 2013