FDA Registration
Active
🇺🇸 United States
SARASOTA MEDICAL PRODUCTS
Reg #: 3009167225
·
FEI: 3009167225
·
Expires 2026
Products
12
Proprietary Names
0
Establishment Types
4
Classifications
12
Registration Details
- Registration Name
- SARASOTA MEDICAL PRODUCTS
- Registration Number
- 3009167225
- FEI Number
- 3009167225
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1451 Sarasota Center Blvd
- City
- Sarasota
- State
- FL
- ZIP
- 34240
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151186
Owner / Operator
- Firm Name
- Sarasota Medical Products
- Operator Number
- 10041215
- Address
- 1451 Sarasota Center Blvd
- City
- Sarasota
- State
- FL
- Postal Code
- 34240
- Country
- US
- Correspondent
- Walt F Leise
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Collector, Ostomy | EXB | Class 1 | Gastroenterology, Urology | No | 2015-03-20 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2015-12-23 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | Class 1 | General, Plastic Surgery | No | 2014-12-04 |
| Dressing, Wound, Occlusive | NAD | Class 1 | General, Plastic Surgery | No | 2013-03-01 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2013-03-01 |
| Appliance, Colostomy, Disposable | EZS | Class 1 | Gastroenterology, Urology | No | 2012-07-02 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2024-04-30 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2021-02-17 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2014-12-04 |
| Bag, Urinary, Ileostomy | EXH | Class 1 | Gastroenterology, Urology | No | 2020-07-17 |
| Bag, Urine Collecting, Ureterostomy | EXG | Class 1 | Gastroenterology, Urology | No | 2020-07-17 |
| Bag, Stomal | GDS | Class 1 | Gastroenterology, Urology | No | 2024-06-21 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Remanufacture Medical Device
Repack or Relabel Medical Device