FDA Registration
Active
🇵🇰 Pakistan
GOLDSTAR MEDICAL INSTRUMENTS
Reg #: 3000126234
·
FEI: 3000126234
·
Expires 2026
Products
19
Proprietary Names
16
Establishment Types
3
Classifications
19
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Registration Details
- Registration Name
- GOLDSTAR MEDICAL INSTRUMENTS
- Registration Number
- 3000126234
- FEI Number
- 3000126234
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Hayat Centre, Khadim Ali Road, Box 2098
- City
- SIALKOT Punjab
- Country
- PK
Regulatory Submissions
- 510(k) Number
- K183665
Owner / Operator
- Firm Name
- Goldstar Medical Instruments
- Operator Number
- 9053992
- Address
- Hayat Centre, Khadim Ali Road, P.O. Box 2098
- City
- Sialkot
- State
- PK-NOTA
- Postal Code
- 51310
- Country
- PK
US Agent
- Business Name
- Regulatory Insight, Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laceration Tray | PKD | Class 1 | General, Plastic Surgery | No | 2024-04-30 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2002-11-25 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2002-11-25 |
| Syringe, Antistick | MEG | Class 2 | General Hospital | No | 2024-04-30 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2024-04-30 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2024-04-30 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2024-04-30 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2024-04-30 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 2003-10-28 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2008-09-25 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2026-01-02 |
| Speculum, Vaginal, Metal | HDF | Class 1 | Obstetrics/Gynecology | No | 2014-09-19 |
| Hook, Tracheal | KCH | Class 1 | Ear, Nose, Throat | No | 2018-09-17 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2024-04-30 |
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2014-03-31 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2024-04-30 |
| Gown, Examination | FME | Class 1 | General Hospital | No | 2024-04-30 |
| Bedding, Disposable, Medical | KME | Class 1 | General Hospital | No | 2024-04-30 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 2016-03-18 |
Proprietary Names
Prepackaged Suture/Laceration Tray
Syringe 10 ml
Needle 18GA x 1.5"
Needle 27GA x 0.5"
Nonwoven Sponge / Gauze 4 x 4
Nonwoven Sponge / Gauze 2 x 2
Adson Forcep (disposable)
TruHold
EMS Tube Holder
Tracheostomy hook
Iris Scissor (disposable)
Webster Needle Holder
Fenestrated Drape
Blotting Towel
Disposable CSR Wrap
Ring Cutter
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)