Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003644849

FEI Number

3003644849

Entity Name

DR. FRIGZ INTERNATIONAL (PVT) LTD.

City/State/Country

SIALKOT, Punjab, PK

Establishment Address

AIRPORT RD., GOHADPUR, SIALKOT, Punjab 51310, PK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DR. FRIGZ INTERNATIONAL (PVT) LTD. (Owner Number: 9050672)

Owner / Operator Contact Address

AIRPORT RD., GOHADPUR, --, SIALKOT, PK-PB 51310, PK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Bone Gouges Lebsche Sternal Knife Schockert Double-end Scleral Depressor Forceps, Rongeur, Surgical Umbilical Cord Clamp Cutter DENTAL SCISSORS SCISSORS, MEDICAL, DISPOSABLE Ligature Needles Eye Specula HEMOSTAT Frazier, Baron, Adson, Yankaur Dental Scalers HEMOSTATIC FORCEPS Plaster Shears, spreaders SOUND, UTERINE All type of Impression Trays, Instruments Trays GENERAL AND PLASTIC SURGERY MIRROR, MOUTH INSTRUMENT, SURGICAL, DISPOSABLE Mouth Gags DENTAL SYRINGE HOOK, TRACHEAL MIRROR, ENT NEEDLE HOLDERS SELF-RETAINING RETRACTOR Clamps Mogen OPHTHALMIC FORCEPS Debakey Forceps, Clamps MIRROR, GENERAL & PLASTIC SURGERY PROBES HANDLE, SCALPEL WAUGH LEEDS CRYER MANGOT.... MULTIPLE BRANDS HARRIS PARMLY RAMSAY Dilators Dental Explorer # 5 Uterine Dilators, Hegar Ear Hook NASAL SPECULA Enucleation Scissors Castroviejo Scissors FORCEPS DILATORS TOOTHED FORCEPS MALLET GIGLI WIRE SAW Laryngoscope, Blade, Bulb, Batery Nail Nipper, Nail Nipper, Concave, Anvil Nail Splitter English Pattern Raspatory, Chisels VARIOUS TYPES OF DEN ALL TYPES OF RETRACTORS BONE FILE METAL RULERS GRADUATED; MEASURING TAPES; Rulers & Calipers Atraumatic Schroeder Tenaculum Forceps WERTHEIM.... MULTIPLE BRANDS MAYO DEAVER GRAZIL Vein Hook BLADE NORSEN DEBRIDER DILATOR, TRACHEAL Spatulas DISSECTOR, TONSIL Dental Elevator DEPRESSOR, TONGUE, NON-SURGICAL Elevators

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDH	Gouge, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-03-28
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2019-07-30
HNX	Depressor, Orbital	Ophthalmic	Class 1	886.4350	2016-07-28
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2008-11-01
HDJ	Scissors, Umbilical	Obstetrics/Gynecology	Class 1	884.4520	2024-05-07
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2022-08-24
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2011-01-13
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	2022-03-28
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2015-02-23
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2011-01-13
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2019-01-23
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2017-03-09
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2007-06-06
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2022-03-28
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2007-06-06
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2022-03-28
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-06-06
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2007-06-06
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2010-12-23
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2022-03-28
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2019-01-23
KCH	Hook, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2011-09-13
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2011-09-13
FHQ	Holder, Needle, Gastroenterologic	Gastroenterology, Urology	Class 1	876.4730	2007-06-06
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2007-06-06
FHA	Clamp, Penile	Gastroenterology, Urology	Class 1	876.5160	2007-11-29
HFX	Clamp, Circumcision	Obstetrics/Gynecology	Class 2	884.4530	2017-06-08
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	2007-06-06
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2020-07-07
FTX	Mirror, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-06-06
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2007-06-06
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2007-06-06
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2002-04-11
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2022-03-28
EKB	Explorer, Operative	Dental	Class 1	872.4565	2017-03-09
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2022-03-28
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2014-05-07
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2007-06-06
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-09-06
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2007-06-06
KCD	Bougie, Esophageal, Ent	Ear, Nose, Throat	Class 1	874.4420	2007-06-06
EMG	Forceps, Tooth Extractor, Surgical	Dental	Class 1	872.4565	2007-06-06
HXL	Mallet	General, Plastic Surgery	Class 1	878.4800	2007-09-14
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	2021-08-28
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2022-03-28
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2026-06-05
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	2022-03-28
EMS	Curette, Periodontic	Dental	Class 1	872.4565	2007-06-06
EIG	Retractor, All Types	Dental	Class 1	872.4565	2007-06-06
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2026-04-25
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2025-06-11
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2016-11-21
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2002-04-11
NJZ	Extractor, Vein	General, Plastic Surgery	Class 1	878.4800	2019-12-10
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2023-09-23
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2011-09-13
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2022-03-28
KBM	Dissector, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2007-11-23
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2019-01-23
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2007-06-06
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2022-03-28

Official Correspondent

Mian Riaz

US Agent Details

ALAN Schwartz Business: MDI CONSULTANTS, INC. Email: alan@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

DR. FRIGZ INTERNATIONAL (PVT) LTD.

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
K894785	Fdt Precision Machine Co., Inc.	SURGICAL CHISEL/OSTEOTOME	1989-08-18
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K143738	Intuit Medical Products, LLC	DSS Sinusplasty Balloon Catheter	2015-08-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
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.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

Similar Registrations

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9612501	Covidien	- Santo Domingo, DO
3011164188	NR SURGICAL COMPANY	Sialkot Punjab, PK
3016069968	SURTEX INSTRUMENTS LTD	London Surrey, GB
3011625373	METRO MEDICAL	Sialkot Punjab, PK
3005440795	XINHUA SURGICAL INSTRUMENT CO. LTD.	ZIBO Shandong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003644849. Last updated year: 2026. Please use registration number 3003644849 when referencing this establishment in official correspondence.