FDA Registration
Active
🇺🇸 United States
QSUM BIOPSY DISPOSABLES LLC
Reg #: 3005675811
·
FEI: 3005675811
·
Expires 2026
Products
5
Proprietary Names
13
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- QSUM BIOPSY DISPOSABLES LLC
- Registration Number
- 3005675811
- FEI Number
- 3005675811
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8624 County Road 1 Sw
- City
- Pequot Lakes
- State
- MN
- ZIP
- 56472
- Country
- US
Regulatory Submissions
- 510(k) Number
- K964142
Owner / Operator
- Firm Name
- QSUM BIOPSY DISPOSABLES LLC
- Operator Number
- 9085466
- Address
- 8624 County Rd 1 SW, --
- City
- Pequot Lakes
- State
- MN
- Postal Code
- 56472
- Country
- US
- Correspondent
- Kelsey - Bean
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2008-05-29 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2006-04-05 |
| Drape, Surgical, Antimicrobial | KKX | Class 2 | General, Plastic Surgery | No | 2006-04-05 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2006-04-05 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2008-05-29 |
Proprietary Names
#11 MRI Disposable Scalpel Kit
STEREOTACTIC BIOPSY TRAY
Basic Interventional Tray
MRI Scalpel/Needle Kit Tray
MRI BIOPSY TRAY
MRI Breast Coil Headrest Drape
MRI Breast Coil Drape
Fischer Stereotactic Table Drape
Lorad Table Drape
Fischer AutoGuide Drape
Interventional Drape
Lorad Stage Drape
MRI 20g x 9cm Inconel Needle
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility