FDA Registration
Active
🇺🇸 United States
PROFESSIONAL SURGICAL INSTRUMENTS CO., INC./PSI
Reg #: 2433825
·
FEI: 1000121617
·
Expires 2026
Products
4
Proprietary Names
16
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- PROFESSIONAL SURGICAL INSTRUMENTS CO., INC./PSI
- Registration Number
- 2433825
- FEI Number
- 1000121617
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 153 MAIN ST.
- City
- E Brunswick
- State
- NJ
- ZIP
- 08816
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172500
Owner / Operator
- Firm Name
- PROFESSIONAL SURGICAL INSTRUMENTS CO., INC.
- Operator Number
- 2433825
- Address
- 153 Main Street, --
- City
- East Brunswick
- State
- NJ
- Postal Code
- 08816
- Country
- US
- Correspondent
- Zainulabedeen Mughal
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2016-08-25 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-05-07 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2025-04-01 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2024-05-20 |
Proprietary Names
Wires
Orthodontic Wires
Arch wires
MASK, SURGICAL
Air Queen; PM95; Pure MSK; Technoweb
4.5" Straight Iris Scissors, Satin With Tip Protector
MD1 Mead Extraction Forceps
23 Cowhorn Extraction Forceps
150 Universal Extraction Forceps, Serrated
151 Universal Extraction Forceps, Serrated
46L English Pattern Extraction Forceps
74N English Pattern Extraction Forceps
Upper Root Tip Extraction Forceps
88R Extraction Forceps
222 Extraction Forceps
88L Extraction Forceps
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device