FDA Registration
Active
🇺🇸 United States
Reusable Disposable Laparoscopic Instrument and Surgical Device and Accessories
Reg #: 3008595179
·
FEI: 3008595179
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- SAC LLC
- Registration Number
- 3008595179
- FEI Number
- 3008595179
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2526 Old Lake Mary Rd.
- City
- Sanford
- State
- FL
- ZIP
- 32773
- Country
- US
Regulatory Submissions
- 510(k) Number
- K101733
Owner / Operator
- Firm Name
- SAC LLC dba Pinnacle Medical Surgical / Orange Surgical Inst
- Operator Number
- 10033801
- Address
- 2526 Old Lake Mary Road
- City
- Sanford
- State
- FL
- Postal Code
- 32773
- Country
- US
- Correspondent
- Michael S Athey
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2022-06-20 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2022-06-20 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2022-06-20 |
| Drape, Surgical | KKX | Class 2 | General, Plastic Surgery | No | 2022-06-20 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2022-06-20 |
Proprietary Names
Reusable Disposable Laparoscopic Instrument and Surgical Device and Accessories
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198