FDA Registration
Active
🇺🇸 United States
THORACENT LLC
Reg #: 3013337852
·
FEI: 3013337852
·
Expires 2026
Products
9
Proprietary Names
11
Establishment Types
1
Classifications
9
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Registration Details
- Registration Name
- THORACENT LLC
- Registration Number
- 3013337852
- FEI Number
- 3013337852
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 120 New York Ave, Suite 6W
- City
- Huntington
- State
- NY
- ZIP
- 11743
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093003
Owner / Operator
- Firm Name
- Thoracent, Inc.
- Operator Number
- 10053873
- Address
- 11 Stewart Ave, Unit 1, Suite 200
- City
- Huntington
- State
- NY
- Postal Code
- 11743
- Country
- US
- Correspondent
- Brian Lynch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stents, Drains And Dilators For The Biliary Ducts | FGE | Class 2 | Gastroenterology, Urology | No | 2017-02-03 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2021-04-13 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2019-01-28 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2019-01-28 |
| Prosthesis, Tracheal, Expandable | JCT | Class 2 | General, Plastic Surgery | No | 2017-02-03 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2019-01-28 |
| Prosthesis, Esophageal | ESW | Class 2 | General, Plastic Surgery | No | 2017-02-03 |
| Snare, Non-Electrical | FGX | Class 1 | Gastroenterology, Urology | No | 2019-01-28 |
| Marker, Colon | NBG | Class 2 | Gastroenterology, Urology | No | 2017-01-18 |
Proprietary Names
Bonastent Biliary
Croc-Bite Forceps
Pinza Forceps
Polyp trap
ITAFLEX - BITEBLOCK
Bonastent Tracheal
ITAFLEX - CLEANING BRUSH
Bonastent Esophageal
ITAFLEX - LOOP-NET
Hilzo Esophageal Stent
pointer
Establishment Types
Complaint File Establishment per 21 CFR 820.198