Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2242656

FEI Number

2242656

Entity Name

VISCOT MEDICAL LLC

City/State/Country

EAST HANOVER, NJ, US

Establishment Address

32 WEST ST., EAST HANOVER, NJ 07936, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

VISCOT MEDICAL LLC (Owner Number: 9068829)

Owner / Operator Contact Address

32 WEST ST., East Hanover, NJ 07936, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K935942

PMA Number

N/A

All Registered Proprietary Names

O.R. MEDICATION MARKING KIT Dukal 20307 Viscot TWENTY-FOUR HOUR C VisDrape Dukal Vismark Medication Label Kit with Waterproof Marker ViXL Ink VISMARK SURGICAL SKIN MARKER R-24

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2023-11-08
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2023-11-08
LYV	Label Or Tag, Sterile	General, Plastic Surgery	Class 1	878.4800	2006-02-23
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2023-11-08
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2023-11-08
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2023-11-08
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2023-11-08
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2023-11-08
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2023-11-08
KBM	Dissector, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2023-11-08
QMX	Label Or Tag, Non-Sterile	General, Plastic Surgery	Class 1	878.4800	2023-11-29
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2023-11-08
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2023-11-08
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2023-11-08
FMH	Container, Specimen, Sterile	Pathology	Class 1	864.3250	1992-07-06
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2023-11-08
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2023-11-08
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2019-06-20
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2023-11-08
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2023-11-08
KBM	Dissector, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2023-11-08
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-04-16
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	1992-07-06
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2023-11-08
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2023-11-16
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2006-02-23
EFQ	Gauze/Sponge, Internal	Unknown	Class U	N/A	2023-11-08

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

VISCOT 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
K861444	Surgical Specialties, Inc.	S1 NASAL PACKING	1986-05-06
K863737	Hermitage Hospital Products, Inc.	SPONGES STERILE TWIN PAKT AND SINGLES	1986-10-14
K940351	Certified Safety Mfg., Inc.	EXTRA LARGE COMPRESS DRESSING	1994-02-25
K950404	Lockett Medical Corp.	LOCKETT MEDICAL CORP. GAUZE	1995-04-17
K790050	Stanford Professional Products	SPONGES, STANFORD STERILE LAP	1979-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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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1018120	Cardinal Health	AUGUSTA, GA, US
1054241	DeRoyal Industries, Inc.	NEW TAZEWELL, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2242656. Last updated year: 2026. Please use registration number 2242656 when referencing this establishment in official correspondence.