FDA Registration
Active
🇺🇸 United States
Kimball Electronics - Indianapolis
Reg #: 3004598644
·
FEI: 3004598644
·
Expires 2026
Products
18
Proprietary Names
7
Establishment Types
1
Classifications
18
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Registration Details
- Registration Name
- Kimball Electronics - Indianapolis
- Registration Number
- 3004598644
- FEI Number
- 3004598644
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2950 N Catherwood Ave
- City
- Indianapolis
- State
- IN
- ZIP
- 46219
- Country
- US
Owner / Operator
- Firm Name
- KIMBALL SOLUTIONS GROUP, LLC
- Operator Number
- 9071700
- Address
- 1205 Kimball Blvd.
- City
- Jasper
- State
- IN
- Postal Code
- 47546
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2016-06-14 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2018-03-27 |
| Injector, Pen | NSC | Class 2 | General Hospital | No | 2022-09-12 |
| Trap, Sterile Specimen | BYZ | Class 2 | General Hospital | No | 2016-06-14 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2016-06-14 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2020-07-06 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2020-07-06 |
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2018-04-18 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2026-03-26 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2017-02-01 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2018-03-27 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2018-03-27 |
| Electrosurgical, Cutting & Coagulation & Accessories, For Cardiac Electrophysiology Device Implantation And Revision | SFQ | Class 2 | General, Plastic Surgery | No | 2025-12-09 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2016-06-14 |
| Motor, Drill, Electric | HBC | Class 2 | Neurology | No | 2022-07-05 |
| Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | ERL | Class 2 | Ear, Nose, Throat | No | 2022-07-05 |
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2020-12-15 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2022-07-19 |
Proprietary Names
AUVI-Q Naloxone HCL Injection, USP Auto-Injector, 10mg
AUVI-Q
Sentio MMG Ball Tip Adjustable Probe
FMS Shaver Blades and Burrs
EG1
Curette
Sytem8 CD NXT Handpiece
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)