FDA Registration
Active
🇺🇸 United States
BihlerMed, LLC
Reg #: 3005977121
·
FEI: 3005977121
·
Expires 2026
Products
7
Proprietary Names
11
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- BihlerMed, LLC
- Registration Number
- 3005977121
- FEI Number
- 3005977121
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 85 INDUSTRIAL DRIVE
- City
- Phillipsburg
- State
- NJ
- ZIP
- 08865
- Country
- US
Regulatory Submissions
- 510(k) Number
- K071180
Owner / Operator
- Firm Name
- BihlerMed, LLC
- Operator Number
- 9092868
- Address
- 85 Industrial Drive
- City
- Phillipsburg
- State
- NJ
- Postal Code
- 08865
- Country
- US
- Correspondent
- Eric Tarnowski
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Intravenous Catheter Force-Activated Separation Device. | QOI | Class 2 | General Hospital | No | 2022-08-04 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2007-01-17 |
| Intraoral Cooling Device | QUA | Class 2 | Dental | No | 2024-03-18 |
| Lamp, Surgical | FTD | Class 2 | General, Plastic Surgery | No | 2008-06-20 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2017-06-09 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2023-08-09 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2007-05-17 |
Proprietary Names
SafeBreak Vascular
Scintillant Retractor
SCINTILLANT LIGHT
Chemo Mouthpiece
Scintillant Surgical Light
Scintillant Dual Tip Surgical Light
SurgiLight
SurgiLight Disposable Handle Assembly
SurgiLight Adapter
Plexitome
Scintillant Suction
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device