FDA Registration
Active
🇺🇸 United States
AURORA SURGICAL, LLC
Reg #: 3009027787
·
FEI: 3009027787
·
Expires 2026
Products
37
Proprietary Names
10
Establishment Types
2
Classifications
37
Registration Details
- Registration Name
- AURORA SURGICAL, LLC
- Registration Number
- 3009027787
- FEI Number
- 3009027787
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 780 94th Avenue N, Suite 108
- City
- St Petersburg
- State
- FL
- ZIP
- 33702
- Country
- US
Owner / Operator
- Firm Name
- Aurora Surgical, LLC
- Operator Number
- 10037164
- Address
- 780 94th Ave N, Suite 108
- City
- St Petersburg
- State
- FL
- Postal Code
- 33702
- Country
- US
- Correspondent
- Lena Jonsson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2011-06-22 |
| Holder, Needle, Gastroenterologic | FHQ | Class 1 | Gastroenterology, Urology | No | 2011-06-22 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2011-06-22 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2011-06-22 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2023-12-07 |
| Clamp, Muscle, Ophthalmic | HOB | Class 1 | Ophthalmic | No | 2011-06-22 |
| Prism, Bar, Ophthalmic | HKW | Class 1 | Ophthalmic | No | 2011-06-22 |
| Clamp, Eyelid, Ophthalmic | HOD | Class 1 | Ophthalmic | No | 2011-06-22 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2011-06-22 |
| Pen, Marking, Surgical | HRP | Class 1 | Ophthalmic | No | 2019-05-30 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2011-06-22 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2023-12-07 |
| Spectacle, Operating (Loupe), Ophthalmic | HOH | Class 1 | Ophthalmic | No | 2011-06-22 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2011-06-22 |
| Punch, Corneo-Scleral | HNJ | Class 1 | Ophthalmic | No | 2023-12-07 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2011-06-22 |
| Curette, Ophthalmic | HNZ | Class 1 | Ophthalmic | No | 2011-06-22 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2011-06-22 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2011-06-22 |
| Elevator, Surgical, General & Plastic Surgery | GEG | Class 1 | General, Plastic Surgery | No | 2011-06-22 |
| Spoon, Ophthalmic | HNB | Class 1 | Ophthalmic | No | 2011-06-22 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2011-06-22 |
| Needle, Ophthalmic Suturing | HNM | Class 1 | Ophthalmic | No | 2011-06-22 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2011-06-22 |
| Trephine, Manual, Ophthalmic | HRH | Class 1 | Ophthalmic | No | 2011-06-22 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2011-06-22 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 2011-06-22 |
| Device, Measuring, Lens Radius, Ophthalmic | HLF | Class 1 | Ophthalmic | No | 2011-06-22 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2011-06-22 |
| Spud, Ophthalmic | HNA | Class 1 | Ophthalmic | No | 2011-06-22 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2011-06-22 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 2011-06-22 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 2011-06-22 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2023-01-26 |
| Ring, Ophthalmic (Flieringa) | HNH | Class 1 | Ophthalmic | No | 2011-06-22 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 2011-06-22 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2011-06-22 |
Proprietary Names
Schocket Double Ended Scleral Depressor
Identification Marking Tape Roll
Instrument Marking Tape
Kelly Punch
Bores Optical Zone Marker
Osher Newman Corneal Marker
Capsulorrhexis Marker
Suture Placement Marker
Corneal Transplant Marker
Hoffer Optical Zone
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device