Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005108347

FEI Number

3001451466

Entity Name

Cygnus Medical LLC

City/State/Country

Branford, CT, US

Establishment Address

965 W Main St, Branford, CT 06405, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MADISON POLYMERIC ENGINEERING (Owner Number: 9028406)

Owner / Operator Contact Address

965 W. MAIN STREET, --, Branford, CT 06405, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Donut Gator Instrument Clip Foot Pedal Cover First Step Kit Clear Path Microfiber Wipers INSTRUMENT TRANSPORT BAG Removable High Level Disinfected (HLD) Label Kangaroo Scope Transport Pad

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2012-08-14
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-08-14
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2018-07-11
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2012-07-26
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2018-07-10
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	2020-06-26
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2020-08-04
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2008-01-10
PXV	General Purpose Instrument Tray	General, Plastic Surgery	Class 1	878.4800	2018-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MADISON POLYMERIC ENGINEERING

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014644369	International Manufacturing Solutions Operaciones	Cd. Juarez Chihuahua, MX
1225691	MADISON POLYMERIC ENGINEERING	BRANFORD, CT, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.

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3003495693	EMERALD NONWOVENS INTL. CO., LTD.	Phetchaburi, TH
3012226300	AVILIGN MEDICAL	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005108347. Last updated year: 2026. Please use registration number 3005108347 when referencing this establishment in official correspondence.