FDA Registration
Active
🇺🇸 United States
7013-5712 MODEL 5712 BLADE (QTY 24) FOR MODEL 600D, 2400Z, AND P8400 THERMAL SCALPEL SYSTEM CONTROLLERS; 7023-5712 MODEL
Reg #: 3006119098
·
FEI: 3006119098
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- HEMOSTATIX MEDICAL TECHNOLOGIES, LLC
- Registration Number
- 3006119098
- FEI Number
- 3006119098
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8400 WOLF LAKE DR., STE. 109
- City
- BARTLETT
- State
- TN
- ZIP
- 38133
- Country
- US
Regulatory Submissions
- 510(k) Number
- K002021
Owner / Operator
- Firm Name
- Critical Care Diagnostics, Inc
- Operator Number
- 10059775
- Address
- 555 E Eliza St
- City
- Schoolcraft
- State
- MI
- Postal Code
- 49087
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-12-30 |
Proprietary Names
7013-5712 MODEL 5712 BLADE (QTY 24) FOR MODEL 600D, 2400Z, AND P8400 THERMAL SCALPEL SYSTEM CONTROLLERS; 7023-5712 MODEL
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device