Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2212018

FEI Number

2212018

Entity Name

PARKER LABORATORIES, INC.

City/State/Country

FAIRFIELD, NJ, US

Establishment Address

286 ELDRIDGE RD., FAIRFIELD, NJ 07004, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PARKER LABORATORIES, INC. (Owner Number: 2212018)

Owner / Operator Contact Address

286 ELDRIDGE RD., --, Fairfield, NJ 07004, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Aquagel Lubricating Gel Timm Medical Lubricating Gel Polysonic Ultrasound Lotion Spectra 360 Electrode Gel Redux Electrolyte Signagel Electrode Gel Gammacore Electrode Gel Brainscope Skin Prep Gel Eclipse Probe Cover Aquasonic 100 Sterile Scan Aquasonic 100 Aquasonic Clear Medvat Clear Unscented Ultrasonic Gel with Aloe Vera Tristel ULT Signaspray Signapad Rebuilder Medical Electrolyte Innovo Spray Electrode Solution and Skin Prep Alpha-Stim Conductive Solution Ultradrape Ultradrape II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2008-02-06
MUI	Media, Coupling, Ultrasound	Radiology	Class 2	892.1570	2014-11-14
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2008-02-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2008-02-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2008-02-19
MUI	Media, Coupling, Ultrasound	Radiology	Class 2	892.1570	2008-02-19
QWS	Foam Or Gel Chemical Sterilant/High Level Disinfectant	General Hospital	Class 2	880.6886	2023-09-22
GYB	Media, Electroconductive	Neurology	Class 2	882.1275	2008-02-19
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2020-01-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-01-22
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-06-21

Official Correspondent

NEAL BUCHALTER

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PARKER LABORATORIES, INC.

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
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2212018. Last updated year: 2026. Please use registration number 2212018 when referencing this establishment in official correspondence.