Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004892425

FEI Number

3004892425

Entity Name

SPARTECH INSTRUMENTS & CO.

City/State/Country

SIALKOT, PUNJAB, PK

Establishment Address

RANGPURA AWANA, BUN LALPURA, SIALKOT, PUNJAB 51310, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SPARTECH INSTRUMENTS & CO. (Owner Number: 9071456)

Owner / Operator Contact Address

RANGPURA AWANA, BUN LALPURA, --, SIALKOT, PUNJAB, PK-NOTA 51310, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ECONO-LN OCHSNER ARTERY STR FORCEP 6-1/4 ECONOMY LINE MAYO-HEGAR NEEDLE ECONOMY LINE HEGAR-BAUMGARTNER ECONOMY LINE WEBSTER NEEDLE. CLAMP RUBBER DAM Ear Speculum Nasal Speculum HOOK, OPHTHALMIC Tongue Tie Probe w/eye Grooved Director Spatula FORCEPS Kelly Forceps tweezers Dressing forceps Bone holding forceps Crocodial Forceps Rib Spreaders Cutting Forceps Mcgee Forceps Nail Cutter Pin Cutter Bone Cutter CALIPER, OPHTHALMIC SCALER, PERIODONTIC Tweezer cannula, trocar, ophthalmic CHISEL, BONE, SURGICAL ECONOMY LINE GRAVES VAGINAL ECONOMY LINE PEDERSON VAGINAL SPECULUM, VAGINAL, METAL HAMMER, SURGICAL TRAY, IMPRESSION, PREFORMED PROBE Handle Tweezers, RETRACTOR Pin wheel FILE CURETTE REMOVER, CROWN ARTICULATORS Bunt Instrument Organizer INSTRUMENTS OTOSCOPE CALIPER CLINICAL USE MULTIPLE TROCAR LARYNGEAL HANDLE, SCALPEL ECONOMY LINE OPERATING SCISS Scissors ECONO LISTER SCISSOR ECONOMY LINE WIRE CUTTING ECONOMY LINE METZENBAUM SCISS SCISSOR BANDAGE LISTER ECONOMY SCISSORS B/B 4 1/2'' CVD ECONOMY LINE MAYO SCISSORS ECONOMY LINE LITTAUER STITCH NO LISTER SCISSOR ECONOMY LINE SPENCER STITCH 1CONOMY LINE MAYO SCISSORS OPTHALMIC SPATULA MATRIX DENTAL FORCEPS, TOOTH EXTRACTOR, SURGICAL Tuning Fork DENTAL AMALGAM OPERATIVE CARVER CARVER GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY SPECULA MIRROR, MOUTH RONGEUR SYRINGE, ENT ECONOMY LINE CRILE ARTERY FCPS ECONOMY LINE HALSTED MOSQUITO ECONOMY LINE KELLY ARTERY FCPS INSTRUMENT, FILLING, PLASTIC, DENTAL BURNISHER, OPERATIVE SAW ophthalmic scissors Stevens Tenotom Scissors Strabiscmus Scissors Iris Scissors SCISSORS SPOON, OPHTHALMIC ELEVATOR DISPOSABLE#GENERAL AND PLASTIC SUR GERY KNIFE, SURGICAL HOOK, SURGICAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2016-12-09
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2016-12-09
EEF	Clamp, Rubber Dam	Dental	Class 1	872.6300	2005-03-17
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2009-04-02
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-12-03
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-03-17
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2005-03-17
HXZ	Cutter, Wire	Orthopedic	Class 1	888.4540	2009-04-02
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-12-03
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2005-03-17
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2009-04-02
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-10-20
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2005-03-17
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2005-03-17
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-03-17
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2005-03-17
HXB	Probe	Orthopedic	Class 1	888.4540	2005-03-17
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2005-03-17
KCX	Epilator, High Frequency, Tweezer-Type	General, Plastic Surgery	Class 1	878.5360	2015-08-05
EIG	Retractor, All Types	Dental	Class 1	872.4565	2005-03-17
GWY	Pinwheel	Neurology	Class 1	882.1750	2013-08-05
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2005-03-17
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2005-03-17
EIS	Remover, Crown	Dental	Class 1	872.4565	2005-03-17
EJP	Articulators	Dental	Class 1	872.3150	2005-03-17
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2005-03-17
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2005-03-17
KTZ	Caliper	Orthopedic	Class 1	888.4150	2005-03-17
HNA	Spud, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-12-03
KAB	Trocar, Laryngeal	Ear, Nose, Throat	Class 1	874.4420	2005-03-17
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2005-03-17
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-10-19
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-12-03
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2005-03-17
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2009-04-02
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2012-10-20
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2005-03-17
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2005-03-17
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-03-17
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2009-04-02
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2005-03-17
HTX	Rongeur	Orthopedic	Class 1	888.4540	2005-03-17
KCP	Syringe, Ent	Ear, Nose, Throat	Class 1	874.5220	2005-03-17
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2016-12-09
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2005-03-17
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2005-03-17
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	2005-03-17
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2005-03-17
HNB	Spoon, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-12-03
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2005-03-17
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2005-07-11
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2005-03-17
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2005-03-17

Official Correspondent

MUHAMMAD BABAR

US Agent Details

Siddiq Azeem Business: A&S International Email: siddiq@asint.biz Phone: (815) 2541110

Related Public Records

Same Entity

SPARTECH INSTRUMENTS & CO.

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
K834189	Imm Enterprises , Ltd.	JAKOBI SURG. INSTRUMENTS #7 44/47	1984-03-06
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0308-2026	Alcon Research LLC	1	Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' 8065000356 27GA HP ENTRY SYSTEM, 4 MM 1 COUNT 8065000358 25GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000359 27GA HP ENTRY SYSTEM, 6 MM 1 COUNT 8065000467 25GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD 8065000468 27GA INFUSION CANNULA(4&6MM ES)+TRAY+TMD Software Version: N/A Product Description: These products are standalone accessory devices meant for vitrectomy surgical procedures. They interface with a corresponding Alcon surgical console. Component: N/A
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-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

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2084346	MARINA MEDICAL INSTRUMENTS, INC.	Davie, FL, US
3004111573	Sterigenics US LLC	Grand Prairie, TX, US
3034525	SIGN Fracture Care International	RICHLAND, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004892425. Last updated year: 2026. Please use registration number 3004892425 when referencing this establishment in official correspondence.