FDA Registration
Active
🇺🇸 United States
Primo Medical Group, INC
Reg #: 1222928
·
FEI: 1000120613
·
Expires 2026
Products
59
Proprietary Names
16
Establishment Types
3
Classifications
59
Registration Details
- Registration Name
- Primo Medical Group, INC
- Registration Number
- 1222928
- FEI Number
- 1000120613
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 75 Mill St
- City
- STOUGHTON
- State
- MA
- ZIP
- 02072
- Country
- US
Owner / Operator
- Firm Name
- Primo Medical Group, Inc
- Operator Number
- 9004401
- Address
- 75 Mill Street
- City
- Stoughton
- State
- MA
- Postal Code
- 02072
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2013-01-30 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2013-01-30 |
| Anchor, Preformed | EJX | Class 1 | Dental | No | 2013-12-17 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2013-12-17 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-11-18 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2013-01-30 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2013-01-30 |
| Mesh, Surgical, Deployment Balloon | OQL | Class 2 | General, Plastic Surgery | No | 2013-01-30 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2013-11-18 |
| Enteroscope And Accessories | FDA | Class 2 | Gastroenterology, Urology | No | 2025-11-20 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2013-01-30 |
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2013-01-30 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2020-11-06 |
| Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer | NJD | Class 2 | Orthopedic | No | 2020-11-06 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2013-03-26 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2023-09-23 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-09-23 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2018-08-02 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2018-08-02 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2018-08-02 |
| Port & Catheter, Implanted, Subcutaneous, Intravascular | LJT | Class 2 | General Hospital | No | 2025-09-02 |
| Urethral Insert With Pump For Bladder Drainage | PIH | Class 2 | Gastroenterology, Urology | No | 2018-09-07 |
| Colonoscope And Accessories, Flexible/Rigid | FDF | Class 2 | Gastroenterology, Urology | No | 2013-01-30 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2024-08-19 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2025-06-23 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2013-06-11 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2013-11-18 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2024-08-19 |
| Device, Thermal Ablation, Endometrial | MNB | Class 3 | Unknown | No | 2020-04-27 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 2013-01-30 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2013-01-30 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2023-11-27 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2024-08-19 |
| Illuminator, Fiberoptic, Surgical Field | HBI | Class 2 | General, Plastic Surgery | No | 2019-09-23 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2019-09-23 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 1992-08-14 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-11-20 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2013-01-30 |
| Graft, Vascular, Stainless Steel Tunneler | MZY | Class 2 | Cardiovascular | No | 2016-02-10 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 1992-08-14 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2019-08-22 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2013-01-30 |
| Prosthesis, Hip, Femoral, Resurfacing | KXA | Class 2 | Orthopedic | No | 2013-01-30 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2013-11-18 |
| Implant, Intragastric For Morbid Obesity | LTI | Class 3 | Unknown | No | 2015-11-06 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2021-05-17 |
| Tubing, Pump, Cardiopulmonary Bypass | DWE | Class 2 | Cardiovascular | No | 2013-06-11 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2014-03-21 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2013-01-30 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2024-08-19 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2013-01-30 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2017-09-20 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2017-09-20 |
| System, Suction, Lipoplasty | MUU | Class 2 | General, Plastic Surgery | No | 2013-05-08 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-11-18 |
| Instrument, Surgical, Disposable | KDC | Class 1 | General, Plastic Surgery | No | 2024-08-19 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2024-08-19 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2023-08-30 |
Proprietary Names
Preformed Anchor
Scan abutment
Bone Tap
Awl
Engage Surgical Pins
STD MED Primo Port Poly
Vesiflo inFlow urinary prosthesis
Instrument Guide
ENDOFLO SUCTION IRRIGATION PROBE
DISP. LAPAROSCOPIC SCISSORS W
ELECTRO SURGICAL FOOT SWITCH
PRIMO PORT
Drill Bit
Caddy
Screwdriver
DiLumen Endolumenal Interventional Platform
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only
Sterilize Medical Device for Another Party (Contract Sterilizer)