Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2434982

FEI Number

2434982

Entity Name

GEMSTAR, INC.

City/State/Country

MONSEY, NY, US

Establishment Address

27 ROBERT PITT DR., MONSEY, NY 10952, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

GEMSTAR, INC. (Owner Number: 2434982)

Owner / Operator Contact Address

27 ROBERT PITT DR., --, Monsey, NY 10952, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K896171

PMA Number

N/A

All Registered Proprietary Names

OTOSCOPE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2017-09-14
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2017-09-14
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2017-09-14
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2017-09-14
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2017-09-14
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2017-09-14
JOJ	Indicator, Physical/Chemical Sterilization Process	General Hospital	Class 2	880.2800	2017-09-14
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2017-09-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-09-14
FRC	Indicator, Biological Sterilization Process	General Hospital	Class 2	880.2800	2017-09-14
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2017-09-14
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2017-09-14

Official Correspondent

EPHRAIM GROSSMAN

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GEMSTAR, 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
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K151482	Bcr Diagnostics, Inc.	BCR-30-min BI and RBIP-ST30 Readout Accessory	2016-02-26
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2007	N/A	2	3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2434982. Last updated year: 2026. Please use registration number 2434982 when referencing this establishment in official correspondence.