FDA Registration
Active
🇺🇸 United States
Lancet
Reg #: 3003674698
·
FEI: 3003674698
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- MedSource Labs, LLC
- Registration Number
- 3003674698
- FEI Number
- 3003674698
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8600 Shelby Court, Suite 100
- City
- Chanhassen
- State
- MN
- ZIP
- 55317
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222034
Owner / Operator
- Firm Name
- MEDSOURCE LABS, LLC
- Operator Number
- 9050135
- Address
- 8600 Shelby Court, Suite 100, --
- City
- Chanhassen
- State
- MN
- Postal Code
- 55317
- Country
- US
- Correspondent
- Emilie Andrews
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2024-06-13 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2024-06-13 |
Proprietary Names
Lancet
Establishment Types
Complaint File Establishment per 21 CFR 820.198