FDA Registration
Active
🇺🇸 United States
RG Medical USA
Reg #: 1057358
·
FEI: 1000208608
·
Expires 2026
Products
25
Proprietary Names
1
Establishment Types
2
Classifications
25
Registration Details
- Registration Name
- RG Medical USA
- Registration Number
- 1057358
- FEI Number
- 1000208608
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 630A Pleasant Grove Rd.
- City
- Mount Juliet
- State
- TN
- ZIP
- 37122
- Country
- US
Regulatory Submissions
- 510(k) Number
- K072753
Owner / Operator
- Firm Name
- RG Medical USA
- Operator Number
- 9007726
- Address
- 630 Pleasant Grove Rd.
- City
- Mount Juliet
- State
- TN
- Postal Code
- 37122
- Country
- US
- Correspondent
- Winfried - Reich
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2009-03-25 |
| Filter, Infusion Line | FPB | Class 2 | General Hospital | No | 2009-03-25 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2009-03-25 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2009-03-25 |
| Scissors, Medical, Disposable | JOK | Class 1 | General Hospital | No | 2009-03-25 |
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2009-03-25 |
| Tray, Irrigation, Sterile | EYN | Class 2 | Gastroenterology, Urology | No | 2009-03-25 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | Class 2 | Ear, Nose, Throat | No | 2009-03-25 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2011-02-09 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2011-02-09 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2018-06-27 |
| Laparoscope, Gynecologic (And Accessories) | HET | Class 2 | Obstetrics/Gynecology | No | 2012-05-25 |
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2012-05-25 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2018-06-28 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2011-02-09 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2010-12-29 |
| Electrosurgical Device | DWG | Class 2 | General, Plastic Surgery | No | 2011-02-09 |
| Mirror, Ent | KAI | Class 1 | Ear, Nose, Throat | No | 2018-01-11 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2018-01-11 |
| Electrode, Electrosurgical, Active, Urological | FAS | Class 2 | Gastroenterology, Urology | No | 2011-02-09 |
| Resectoscope, Working Element | FDC | Class 2 | Gastroenterology, Urology | No | 2011-02-09 |
| Resectoscope | FJL | Class 2 | Gastroenterology, Urology | No | 2011-02-09 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2011-02-09 |
| Forceps, Biopsy, Gynecological | HFB | Class 1 | Obstetrics/Gynecology | No | 2011-02-09 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2018-01-11 |
Proprietary Names
RG Medical
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device