FDA Registration
Active
🇵🇰 Pakistan
T.A. WALTHEM & COMPANY
Reg #: 3003407244
·
FEI: 3003407244
·
Expires 2026
Products
70
Proprietary Names
70
Establishment Types
1
Classifications
70
Registration Details
- Registration Name
- T.A. WALTHEM & COMPANY
- Registration Number
- 3003407244
- FEI Number
- 3003407244
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- SUBLIME CHOWK, WAZIRABAD RD.
- City
- SIALKOT PUNJAB
- Country
- PK
Regulatory Submissions
- 510(k) Number
- K152400
Owner / Operator
- Firm Name
- T.A. WALTHEM & COMPANY
- Operator Number
- 9073915
- Address
- SUBLIME CHOWK, WAZIRABAD RD., --
- City
- SIALKOT PUNAJB
- State
- PK-NOTA
- Postal Code
- PB 51310
- Country
- PK
- Correspondent
- ZESHAN - TARIQ
US Agent
- Business Name
- SONTEC INSTRUMENTS INC
- Contact Name
- Johann Scanlan
- Address
- 7248-S.Tucson Way
- City
- Centennial
- State
- CO
- ZIP
- 80112
- Country
- US
- [email protected]
- Phone
- 303 7909411
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2013-02-11 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2019-05-22 |
| Rasp, Surgical, General & Plastic Surgery | GAC | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Trocar, Laryngeal | KAB | Class 1 | Ear, Nose, Throat | No | 2005-06-08 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2005-06-08 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Rasp, Nasal | KBA | Class 1 | Ear, Nose, Throat | No | 2019-05-22 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2019-05-22 |
| Clamp, Rubber Dam | EEF | Class 1 | Dental | No | 2005-06-08 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2005-06-08 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2005-06-08 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2013-02-11 |
| Probe | HXB | Class 1 | Orthopedic | No | 2005-06-08 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2019-05-23 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2019-05-22 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2005-06-08 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2005-06-08 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2005-06-08 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2013-02-11 |
| Speculum, Ent | EPY | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2005-06-08 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 2005-06-08 |
| Syringe, Ent | KCP | Class 1 | Ear, Nose, Throat | No | 2005-06-08 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2005-06-08 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2005-06-08 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Fork, Tuning | GWX | Class 1 | Neurology | No | 2005-06-08 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2019-05-23 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2005-06-08 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2005-06-08 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2019-05-23 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2005-06-08 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2019-05-22 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Articulators | EJP | Class 1 | Dental | No | 2005-06-08 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2005-06-08 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Gag, Mouth | KBN | Class 1 | Ear, Nose, Throat | No | 2005-06-08 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2019-05-22 |
| Remover, Crown | EIS | Class 1 | Dental | No | 2005-06-08 |
| Clamp, Non-Electrical | FFN | Class 1 | Gastroenterology, Urology | No | 2019-05-22 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2019-05-23 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2019-05-22 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2019-05-22 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2013-02-11 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 2005-06-08 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2005-06-08 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2019-05-22 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2005-06-08 |
| Saw | HSO | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2005-06-08 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2013-02-11 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 2013-02-11 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2005-06-08 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2005-06-08 |
| Carver, Dental Amalgam, Operative | EKH | Class 1 | Dental | No | 2005-06-08 |
| Depressor, Metal Tongue, Surgical | KBL | Class 1 | Ear, Nose, Throat | No | 2005-06-08 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2019-05-23 |
Proprietary Names
Specula, ophthalmic
MALLET
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
RASP, SURGICAL, GENERAL & PLASTIC SURGERY
TROCAR, LARYNGEAL
HANDLE, INSTRUMENT, DENTAL
OSTEOTOME, MANUAL
RASP, NASAL
KNIFE, ORTHOPEDIC
CLAMP, RUBBER DAM
EXPLORER, OPERATIVE
HAMMER, SURGICAL
SCISSORS, ORTHOPEDIC, SURGICAL
CLAMP
PROBE
CATHETER AND TIP, SUCTION
Forceps, ophthalmic
SCALER, PERIODONTIC
RETRACTOR, ALL TYPES
INSTRUMENT, FILLING, PLASTIC, DENTAL
FORCEPS, ENT
SPECULUM, ENT
FORCEPS
HANDLE, SCALPEL
CHISEL, BONE, SURGICAL
BURNISHER, OPERATIVE
SYRINGE, ENT
ELEVATOR, SURGICAL, DENTAL
SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY
MIRROR, MOUTH
GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY
FORK, TUNING
DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY
HOLDER, NEEDLE, GASTROENTEROLOGIC
CALIPER
CHISEL (OSTEOTOME)
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Laparoscope, general & plastic surgery
TRAY, IMPRESSION, PREFORMED
AWL
CURETTE
ARTICULATORS
SPECULUM, VAGINAL, METAL
HOOK, SURGICAL, GENERAL & PLASTIC SURGERY
GAG, MOUTH
ELEVATOR
RETRACTOR, SELF-RETAINING
REMOVER, CROWN
CLAMP, NON-ELECTRICAL
KNIFE, SURGICAL
FORCEPS, GENERAL & PLASTIC SURGERY
INSTRUMENT, COMPRESSION
Caliper, ophthalmic
RASP
OSTEOTOME
RETRACTOR
CARVER, WAX, DENTAL
EXCAVATOR, DENTAL, OPERATIVE
RETRACTOR, NON-SELF-RETAINING
FILE, BONE, SURGICAL
SAW
TRAY, SURGICAL, INSTRUMENT
INSTRUMENTS, DENTAL HAND
SCISSORS, OPHTHALMIC
CURETTE, EAR
RONGEUR
PLIERS, SURGICAL
CARVER, DENTAL AMALGAM, OPERATIVE
DEPRESSOR, METAL TONGUE, SURGICAL
BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
Establishment Types
Manufacture Medical Device