FDA Registration
Active
🇺🇸 United States
HART ENTERPRISES, INC.
Reg #: 1828424
·
FEI: 1828424
·
Expires 2026
Products
11
Proprietary Names
18
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- HART ENTERPRISES, INC.
- Registration Number
- 1828424
- FEI Number
- 1828424
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 400 APPLEJACK CT.
- City
- SPARTA
- State
- MI
- ZIP
- 49345
- Country
- US
Owner / Operator
- Firm Name
- HART ENTERPRISES, INC.
- Operator Number
- 1828424
- Address
- 400 APPLEJACK CT., --
- City
- Sparta
- State
- MI
- Postal Code
- 49345
- Country
- US
- Correspondent
- ROBERT L STRIEBEL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2007-12-14 |
| Catheter, Cholangiography | GBZ | Class 1 | General, Plastic Surgery | No | 2002-04-11 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2007-12-14 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2007-12-14 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2007-12-14 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2012-08-07 |
| Needle, Biopsy, Cardiovascular | DWO | Class 1 | General, Plastic Surgery | No | 2007-12-14 |
| Needle, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2007-12-14 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 2007-12-14 |
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 1994-10-05 |
| Endoscopic Injection Needle, Gastroenterology-Urology | FBK | Class 2 | Gastroenterology, Urology | No | 2012-11-28 |
Proprietary Names
Myelography Needle
CHIBA NEEDLE
Cournand Needle
Sure-Grip Flashback
Madayag Needle
Seldinger Needle
Biogun
Wescott Needle
MYELOGRAPHY
Spinal Needle
Spine Needle
Chiba Needle
Biopsy Needle Insert
Breast Localization Needle
NEEDLE INSERT FOR SOFT TISSUE BIOPS
WESTCOTT STYLE
BIOGUN
NOTCH NEEDLE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Sterilize Medical Device for Another Party (Contract Sterilizer)