FDA Registration
Active
🇺🇸 United States
GEMSTAR, INC.
Reg #: 2434982
·
FEI: 2434982
·
Expires 2026
Products
14
Proprietary Names
2
Establishment Types
1
Classifications
14
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Registration Details
- Registration Name
- GEMSTAR, INC.
- Registration Number
- 2434982
- FEI Number
- 2434982
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 27 ROBERT PITT DR.
- City
- MONSEY
- State
- NY
- ZIP
- 10952
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093199
Owner / Operator
- Firm Name
- GEMSTAR, INC.
- Operator Number
- 2434982
- Address
- 27 ROBERT PITT DR., --
- City
- Monsey
- State
- NY
- Postal Code
- 10952
- Country
- US
- Correspondent
- EPHRAIM - GROSSMAN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2017-09-14 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2017-09-14 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2017-09-14 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2017-09-14 |
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2017-09-14 |
| Stethoscope, Manual | LDE | Class 1 | Cardiovascular | No | 2017-09-14 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2017-09-14 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2017-09-14 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2017-09-14 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2017-09-14 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2017-09-14 |
| Speculum, Vaginal, Nonmetal | HIB | Class 2 | Obstetrics/Gynecology | No | 2017-09-14 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2017-09-14 |
| Bandage, Liquid | KMF | Class 1 | General Hospital | No | 2017-09-14 |
Proprietary Names
OTOSCOPE
Electrode
Establishment Types
Repack or Relabel Medical Device