FDA Registration
Active
🇺🇸 United States
AMERICAN SURGICAL COMPANY, LLC
Reg #: 1221144
·
FEI: 1221144
·
Expires 2026
Products
5
Proprietary Names
11
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- AMERICAN SURGICAL COMPANY, LLC
- Registration Number
- 1221144
- FEI Number
- 1221144
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 100 Cummings Center, Suite 151-G
- City
- Beverly
- State
- MA
- ZIP
- 01915
- Country
- US
Regulatory Submissions
- 510(k) Number
- K854713
Owner / Operator
- Firm Name
- American Surgical Company, LLC
- Operator Number
- 10030544
- Address
- 100 Cummings Center, Suite 151-G
- City
- Beverly
- State
- MA
- Postal Code
- 01915
- Country
- US
- Correspondent
- Erik Piasio
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neurosurgical Paddie | HBA | Class 2 | Neurology | No | 2009-10-15 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2018-10-11 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2009-11-10 |
| Eye Tray | OJK | Class 2 | Ophthalmic | No | 2018-03-20 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2026-03-13 |
Proprietary Names
Ultracot Sponges
Americot Surgical Sponges
Ophthalmic Pledget
Telfa Sponges
Surgical Cotton Balls
Uniqcot
Delicot
Ray-cot
Tapered Delicot
Comfort Pack
BioBrush
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)