Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007773213

FEI Number

3007773213

Entity Name

SITEC (PVT.) LTD.

City/State/Country

SIALKOT Punjab, PK

Establishment Address

Rai Pur,, 10km Wazirabad Road, SIALKOT Punjab 51310, PK

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

SITEC (Pvt.) Ltd. (Owner Number: 10029945)

Owner / Operator Contact Address

Rai Pur, 10km Wazirabad Road, 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

Chisel, Bone, Surgical Instrument Trays Forceps, Rongeur, Surgical Vaginal Speculum EXPANDER, SURGICAL, SKIN GRAFT Dilator, Catheter Nasal Forceps FORCEPS ENT Weil-Blakesley Nasal Forceps Drills, Burrs, Trephines Scoop Probe & Director, Gastro-Urology Introducer, Sphere Contractor, Surgical Tongue Depressor, Metal, Surgical Mouth Gag Curette Scissors, Gen. & Plastic Surgery Probe, Ent Hook, Fibroid, Gynecological Burr, Corneal, Manual Instruments, Dental Hand Self-Retaining Retractors SITEC Orthopedic Surgical Scissors Scissors, Collar and Crown Uterine Sound Chisel, Osteotome, Dental Surgical Retractor, Non-Self-Retaining Rongeur, Orthopedic Osteotome, Manual Plugger, Root Canal, Endodontic Tube, Tonsil Suction Tubing Clamp Tubing Clamp with Guard Hook, Gastro-Urology Dermatome Caliper Clamps Surgical, General & Plastic Surgery Hand, External Limb Reamer File, Bone, Surgical Applicator, Ent Surgical Pliers Orthopedic Surgical Instruments Retractor, Gen. & Plastic Surgery Elevators, Gen. & Plastic Surgery Retractor, ENT Finger Ring Cutter Lachrymal Probe Dilator, Cervical McGivney Hemorrhoidal Ligature Hemostat Forceps, General & Plastic Surgery Cannula, Surgical, General & Plastic Surgery Knife, Myringotomy Surgical Dental Hemostats, Various Dissector, Surgical, General & Plastic Surgery Hook, Surgical, General & Plastic Surgery Marker, Sclera Grasping Forceps Speculum, ENT Tracheal Dilator TRAY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2012-02-14
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	2014-02-24
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2012-11-30
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2020-12-29
HDF	Speculum, Vaginal, Metal	Obstetrics/Gynecology	Class 1	884.4520	2012-02-14
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2022-07-02
GCC	Dilator, Catheter	General, Plastic Surgery	Class 1	878.4200	2012-02-14
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2017-08-01
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2016-06-03
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	2020-12-29
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2012-02-14
HNP	Introducer, Sphere	Ophthalmic	Class 1	886.4350	2020-12-29
FZR	Contractor, Surgical	General, Plastic Surgery	Class 1	878.4800	2020-12-29
KBL	Depressor, Metal Tongue, Surgical	Ear, Nose, Throat	Class 1	874.4420	2009-07-20
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2012-02-14
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	2012-02-14
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-07-20
KAK	Probe, Ent	Ear, Nose, Throat	Class 1	874.4420	2012-02-14
HDE	Hook, Fibroid, Gynecological	Obstetrics/Gynecology	Class 1	884.4520	2020-12-29
HOF	Burr, Corneal, Manual	Ophthalmic	Class 1	886.4350	2020-12-29
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2012-02-14
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2016-03-03
HRR	Scissors, Orthopedic, Surgical	Orthopedic	Class 1	888.4540	2012-02-14
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	2016-06-07
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	2012-02-14
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2009-07-20
FGN	Retractor, Non-Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2020-12-29
HTX	Rongeur	Orthopedic	Class 1	888.4540	2009-07-20
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2020-12-29
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	2020-12-29
KCB	Tube, Tonsil Suction	Ear, Nose, Throat	Class 1	874.4420	2012-02-14
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2016-12-07
FHB	Hook, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	2020-12-29
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2020-12-29
KTZ	Caliper	Orthopedic	Class 1	888.4150	2012-02-14
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-30
IRA	Hand, External Limb Component, Mechanical	Physical Medicine	Class 1	890.3420	2012-02-14
HTO	Reamer	Orthopedic	Class 1	888.4540	2020-12-29
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2012-02-14
KCJ	Applicator, Ent	Ear, Nose, Throat	Class 1	874.5220	2020-12-29
HTC	Pliers, Surgical	General, Plastic Surgery	Class 1	878.4800	2009-07-20
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-02-14
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2009-07-20
GEG	Elevator, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-07-20
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2016-05-31
FNS	Ring Cutter	General Hospital	Class 1	880.6200	2021-03-12
HNL	Probe, Lachrymal	Ophthalmic	Class 1	886.4350	2012-02-14
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	2012-02-14
HCF	Instrument, Ligature Passing And Knot Tying	General, Plastic Surgery	Class 1	878.4800	2018-05-19
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2009-07-20
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2009-07-20
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-02-14
JYP	Knife, Myringotomy	Ear, Nose, Throat	Class 1	874.4420	2020-12-29
EMD	Hemostat, Surgical	Dental	Class 1	872.4565	2009-07-20
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-11-30
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2012-02-14
HMQ	Marker, Sclera	Ophthalmic	Class 1	886.4570	2020-12-29
KOA	Surgical Instruments, G-U, Manual (And Accessories)	Gastroenterology, Urology	Class 1	876.4730	2016-04-08
EPY	Speculum, Ent	General, Plastic Surgery	Class 1	878.1800	2009-07-20
KCG	Dilator, Tracheal	Ear, Nose, Throat	Class 1	874.4420	2012-02-14
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2025-09-08

Official Correspondent

Irfan Farooq

US Agent Details

Dagmar Maser Business: BUSINESS SUPPORT INTERNATIONAL Email: info@bsi-fda.com Phone: (212) 3318358

Related Public Records

Same Entity

SITEC (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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K851170	The Huxley Instrument Corp.	DISSECTING TWEEZER #283-72PCS. SS 410	1985-04-25
K821248	Conphar, Inc.	ROCHESTER PEAN FORCEPS	1982-05-28

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486

Similar Registrations

Registration Number	Establishment Name	Location
1032227	BRASSELER U.S.A. DENTAL, LLC	SAVANNAH, GA, US
3015398570	MEISTER SURGICAL INSTRUMENTS	Sialkot Punjab, PK
3008808049	SURGICRAFTS	Sialkot Punjab, PK
9613083	TOWNE BROTHERS (PVT.), LTD.	SIALKOT Punjab, PK
3036756245	STRAITS ORTHOPAEDICS (MFG) SDN BHD	Perai Pulau Pinang, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007773213. Last updated year: 2026. Please use registration number 3007773213 when referencing this establishment in official correspondence.