FDA Registration
Active
🇺🇸 United States
HURRICANE MEDICAL
Reg #: 1064005
·
FEI: 3002590787
·
Expires 2026
Products
9
Proprietary Names
13
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- HURRICANE MEDICAL
- Registration Number
- 1064005
- FEI Number
- 3002590787
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5315 LENA ROAD
- City
- BRADENTON
- State
- FL
- ZIP
- 34211
- Country
- US
Regulatory Submissions
- 510(k) Number
- K990671
Owner / Operator
- Firm Name
- HURRICANE MEDICAL
- Operator Number
- 9036203
- Address
- 5315 LENA ROAD, --
- City
- Bradenton
- State
- FL
- Postal Code
- 34211
- Country
- US
- Correspondent
- Gabriel Rodriguez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cystotome | HNY | Class 1 | Ophthalmic | No | 1999-01-20 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 1999-01-20 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2007-11-19 |
| Unit, Filter, Membrane | JRL | Class 1 | Clinical Chemistry | No | 2000-01-18 |
| Lens, Guide, Intraocular | KYB | Class 1 | Ophthalmic | No | 1999-09-23 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2007-10-18 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 1999-01-20 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 1999-01-20 |
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 1999-09-23 |
Proprietary Names
IRRIGATING CYSTOTOME
IRRIGATION AND ASPIRATION CANNULA
Incise Film
UNIT
FILTER
MEMBRANE
SURGICAL GLIDE
Wick, Spear, Sponge, Light Shield
RETROBULBAR NEEDLES
ANESTHESIA PERIBULBAR
EYE SHIELD
LIGHT SHIELD
Hurricane Medical Marker Pads and Marker Pens
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)