FDA Registration
Active
🇺🇸 United States
HERAEUS MEDICAL COMPONENTS, LLC
Reg #: 3008988055
·
FEI: 3008988055
·
Expires 2026
Products
9
Proprietary Names
2
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- HERAEUS MEDICAL COMPONENTS, LLC
- Registration Number
- 3008988055
- FEI Number
- 3008988055
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5030 Centerville Road
- City
- Saint Paul
- State
- MN
- ZIP
- 55127
- Country
- US
Regulatory Submissions
- 510(k) Number
- K012861
Owner / Operator
- Firm Name
- Heraeus Medical Components, LLC
- Operator Number
- 9045241
- Address
- 5030 Centerville Road
- City
- Saint Paul
- State
- MN
- Postal Code
- 55127
- Country
- US
- Correspondent
- Timothy Desaulniers
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2007-10-16 |
| Endoscopic Guidewire, Gastroenterology-Urology | OCY | Class 2 | Gastroenterology, Urology | No | 2015-03-26 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2022-08-10 |
| Permanent Pacemaker Electrode | DTB | Class 3 | Cardiovascular | No | 2022-08-10 |
| Stimulator, Peripheral Nerve, Implanted (Pain Relief) | GZF | Class 2 | Neurology | No | 2022-09-15 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2022-08-02 |
| Device, Percutaneous Retrieval | MMX | Class 2 | Cardiovascular | No | 2016-03-31 |
| Stylet For Catheter, Gastro-Urology | EZB | Class 1 | Gastroenterology, Urology | No | 2014-09-11 |
| Stimulator, Spinal-Cord, Implanted (Pain Relief) | GZB | Class 2 | Neurology | No | 2022-09-15 |
Proprietary Names
Vascupuncture Guidewires
Spring Coil Guidewire
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)