Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2132242

FEI Number

1000143837

Entity Name

Stellen Medical, LLC

City/State/Country

Saint Paul, MN, US

Establishment Address

1290 HAMMOND RD., Saint Paul, MN 55110, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

STELLEN MEDICAL, LLC (Owner Number: 9008931)

Owner / Operator Contact Address

1290 HAMMOND RD., --, Saint Paul, MN 55110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K111436

PMA Number

N/A

All Registered Proprietary Names

GlucanPro Cream Brennen Skin Graft Mesher Proformix

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic	Unknown	Class U	N/A	2007-12-12
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	1994-01-13
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2011-12-27

Official Correspondent

Katherine Perkey

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STELLEN MEDICAL, LLC

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
K954741	Derma Sciences, Inc.	DERMAGRAN WENT DRESSING (DEXTROSE-SALINE)	1995-11-01
K134033	Miromatrix Medical, Inc.	MIROMATRIX BIOLOGICAL MESH	2014-03-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-05	DeRoyal Wound Care	U	Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part *SterileManufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA**
Z-0039-2020	AZIYO BIOLOGICS	2	BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Z-0040-2020	AZIYO BIOLOGICS	2	CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

Similar Registrations

Registration Number	Establishment Name	Location
3024971708	Carowinds	Charlotte, NC, US
1043214	DEROYAL INDUSTRIES, INC.	POWELL, TN, US
9680091	DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.)	TORONTO Ontario, CA
1058584	Sterigenics US LLC	Charlotte, NC, US
1921846	Cardinal Health	Hazelwood, MO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2132242. Last updated year: 2026. Please use registration number 2132242 when referencing this establishment in official correspondence.