FDA Registration
Active
🇵🇰 Pakistan
SITEC (PVT.) LTD.
Reg #: 3007773213
·
FEI: 3007773213
·
Expires 2026
Products
85
Proprietary Names
93
Establishment Types
3
Classifications
85
Registration Details
- Registration Name
- SITEC (PVT.) LTD.
- Registration Number
- 3007773213
- FEI Number
- 3007773213
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rai Pur,, 10km Wazirabad Road
- City
- SIALKOT Punjab
- Country
- PK
Regulatory Submissions
- 510(k) Number
- K902818
Owner / Operator
- Firm Name
- SITEC (Pvt.) Ltd.
- Operator Number
- 10029945
- Address
- Rai Pur, 10km Wazirabad Road
- City
- SIALKOT
- State
- Punjab
- Postal Code
- 51310
- Country
- PK
- Correspondent
- Irfan Farooq
US Agent
- Business Name
- BUSINESS SUPPORT INTERNATIONAL
- Contact Name
- Dagmar Maser
- Address
- 1350 Avenue of the Americas, 2nd Floor
- City
- New York
- State
- NY
- ZIP
- 10019
- Country
- US
- [email protected]
- Phone
- 212 3318358
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2012-02-14 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2014-02-24 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2012-11-30 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2020-12-29 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2012-02-14 |
| Expander, Surgical, Skin Graft | FZW | Class 1 | General, Plastic Surgery | No | 2022-07-02 |
| Dilator, Catheter | GCC | Class 1 | General, Plastic Surgery | No | 2012-02-14 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2017-08-01 |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | Class 2 | Neurology | No | 2016-06-03 |
| Scoop | FHL | Class 1 | Gastroenterology, Urology | No | 2020-12-29 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 2012-02-14 |
| Introducer, Sphere | HNP | Class 1 | Ophthalmic | No | 2020-12-29 |
| Contractor, Surgical | FZR | Class 1 | General, Plastic Surgery | No | 2020-12-29 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2009-07-20 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2012-02-14 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2012-02-14 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2009-07-20 |
| Probe, Ent | KAK | Class 1 | Ear, Nose, Throat | No | 2012-02-14 |
| Hook, Fibroid, Gynecological | HDE | Class 1 | Obstetrics/Gynecology | No | 2020-12-29 |
| Burr, Corneal, Manual | HOF | Class 1 | Ophthalmic | No | 2020-12-29 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2012-02-14 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2016-03-03 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2012-02-14 |
| Scissors, Collar And Crown | EIR | Class 1 | Dental | No | 2016-06-07 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 2012-02-14 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 2009-07-20 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2020-12-29 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2009-07-20 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2020-12-29 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 2020-12-29 |
| Tube, Tonsil Suction | KCB | Class 1 | Ear, Nose, Throat | No | 2012-02-14 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2016-12-07 |
| Hook, Gastro-Urology | FHB | Class 1 | Gastroenterology, Urology | No | 2020-12-29 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 2020-12-29 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2012-02-14 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2012-11-30 |
| Hand, External Limb Component, Mechanical | IRA | Class 1 | Physical Medicine | No | 2012-02-14 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2020-12-29 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2012-02-14 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2020-12-29 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2009-07-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2012-02-14 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2009-07-20 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2009-07-20 |
| Retractor, Ent | KAL | Class 1 | Ear, Nose, Throat | No | 2016-05-31 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 2021-03-12 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 2012-02-14 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 2012-02-14 |
| Instrument, Ligature Passing And Knot Tying | HCF | Class 1 | General, Plastic Surgery | No | 2018-05-19 |
| Hemostat | HRQ | Class 1 | General, Plastic Surgery | No | 2009-07-20 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2009-07-20 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2012-02-14 |
| Knife, Myringotomy | JYP | Class 1 | Ear, Nose, Throat | No | 2020-12-29 |
| Hemostat, Surgical | EMD | Class 1 | Dental | No | 2009-07-20 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2012-11-30 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2012-02-14 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2020-12-29 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2016-04-08 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2009-07-20 |
| Dilator, Tracheal | KCG | Class 1 | Ear, Nose, Throat | No | 2012-02-14 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2025-09-08 |
| Saw, Nasal | KBC | Class 1 | Ear, Nose, Throat | No | 2020-12-29 |
| Counter, Sponge, Surgical | LWH | Class 1 | General Hospital | No | 2009-07-20 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2009-07-20 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2020-12-29 |
| Handpiece (Brace), Drill | HBD | Class 1 | Neurology | No | 2020-12-29 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2009-07-20 |
| Skid, Bone | HWO | Class 1 | Orthopedic | No | 2009-07-20 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2012-02-14 |
| Probe | HXB | Class 1 | Orthopedic | No | 2012-02-14 |
| Syringe, Irrigating (Dental) | EIB | Class 1 | Dental | No | 2020-11-20 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2016-03-08 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2009-07-20 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2012-02-14 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2012-02-14 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2012-02-14 |
| Facebow | KCR | Class 1 | Dental | No | 2020-12-29 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2020-12-29 |
| Cannula, Ventricular | HCD | Class 1 | Neurology | No | 2020-12-29 |
| Forceps, Obstetrical | HDA | Class 2 | Obstetrics/Gynecology | No | 2017-03-01 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2009-07-20 |
| Cannula And Trocar, Suprapubic, Non-Disposable | FBM | Class 1 | Gastroenterology, Urology | No | 2014-01-03 |
| Holder, Speculum, Ent | KAG | Class 1 | General, Plastic Surgery | No | 2012-02-14 |
| Forceps, Tooth Extractor, Surgical | EMG | Class 1 | Dental | No | 2009-07-20 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2009-07-20 |
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
Saw, Nasal
Counter Sponge, Surgical
Neurological Instrument,Non-Powered
Mirror, Ent
Handpiece (Brace), Drill
Forceps
Bone Skid
Cutter, Surgical
Probe
Syringe, Irrigating (Dental)
Dental Retractors
Surgical Hammers, Various
Tuning Fork
Mouth Mirror
Knife, Surgical
Facebow
Spoon, Ophthalmic
Cannula, Ventricular
Naegele Obstetrical Forceps
Kielland Obstetrical Forceps
DeLee Obstetrical Forceps
Simpson Obstetrical Forceps
Wrigley Obstetrical Forceps
Piper Obstetrical Forceps
Gastroenterologic Needle Holders
Reusable Cannula, Trocar
Killian Septum Speculum
Holder, Speculum. Ent
Surgical Tooth Extractor Forceps
Scalpel Handle
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device