FDA Registration
Active
🇺🇸 United States
PMC SMART Solutions, LLC
Reg #: 3010408671
·
FEI: 3010408671
·
Expires 2026
Products
13
Proprietary Names
17
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- PMC SMART Solutions, LLC
- Registration Number
- 3010408671
- FEI Number
- 3010408671
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1451 S. Miller Avenue
- City
- Shelbyville
- State
- IN
- ZIP
- 46176
- Country
- US
Owner / Operator
- Firm Name
- PMC SMART Solutions
- Operator Number
- 10044542
- Address
- 1451 S. Miller Avenue
- City
- Shelbyville
- State
- IN
- Postal Code
- 46176
- Country
- US
- Correspondent
- Jeffrey D Burris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2020-02-11 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2021-04-15 |
| Endoscope Channel Accessory | ODC | Class 2 | Gastroenterology, Urology | No | 2019-04-09 |
| Clip, Implantable | FZP | Class 2 | General, Plastic Surgery | No | 2025-02-18 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2026-05-28 |
| System, Ablation, Ultrasound And Accessories | NTB | Class 2 | General, Plastic Surgery | No | 2013-07-25 |
| Clip, Scalp | HBO | Class 2 | Neurology | No | 2016-08-04 |
| Shunt, Central Nervous System And Components | JXG | Class 2 | Neurology | No | 2018-05-18 |
| Modular Electromechanical Surgical System | SCV | Class 2 | General, Plastic Surgery | No | 2026-01-05 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-11-30 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2013-06-25 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2020-11-30 |
| Trap, Sterile Specimen | BYZ | Class 2 | General Hospital | No | 2020-07-31 |
Proprietary Names
Sonopet Disposable Tubing Set and Extender Filter Tubing
Eikon LT 40mm, Narrow
Eikon LT 135mm, Sweetheart
Eikon LT, 175mm
CleverLock Guidewire Locking Device and Biopsy Cap
GemZipclip
PhotonGuide Illuminator, Narrow/ Flat
PhotonGuide Illuminator, Wide/ Flat
Sonatherm
MEDTRONIC CLIP GUN
45805 STRATA II ADJUSTMENT KIT
45805 Strata II Adjustment Tool
Hugo Robotically Assisted Surgery (RAS) System
4.5mm RTD Twist Drill
Vizadisc
Carpal Tunnel Release Instruments
Bone Vac
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)