FDA Registration
Active
🇺🇸 United States
INFINITUS MEDICAL TECHNOLOGIES LLC
Reg #: 3010396722
·
FEI: 3010396722
·
Expires 2026
Products
4
Proprietary Names
16
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- INFINITUS MEDICAL TECHNOLOGIES LLC
- Registration Number
- 3010396722
- FEI Number
- 3010396722
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 242 South Main St, Suite 214
- City
- Holly Springs
- State
- NC
- ZIP
- 27540
- Country
- US
Owner / Operator
- Firm Name
- Infinitus Medical Technologies LLC
- Operator Number
- 10044733
- Address
- 1308 Honey Locust Ct
- City
- Raleigh
- State
- NC
- Postal Code
- 27606
- Country
- US
- Correspondent
- David J Gomez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-04-16 |
| Surgical Table Cushion | LWG | Class 1 | General, Plastic Surgery | No | 2021-12-23 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2017-01-08 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2013-07-19 |
Proprietary Names
COVID19 Reponse PPE Hood
IMT Surgical Replacement pad set for various surgical table manufactures
Mizuho Hana Table Pad and Strap PN FPLS-1210SP
The Kyber SSC Retractor assembly
AXR-2000 Pressure Management Foam Wedge
LUNA Supine Pad SP-3500
Azul ITPW
Pneuma Hadron FPLS (inflatable assist positioning system)
The Hadron FPLS" Foam Pad Lift System
Visiwrap Robotic face protection system
CHST-3000 Chest Pad and Chest Strap Accessory Kit
Pneuma Genesis Bi-Wing AAP Inflatable Assist Positioning System
FPLS-3000-Wing
ION ESPS Foam insert
The Genesis Bi-Wing AAP arm adduction pad
The iON ESPS ergonomic surgical postioning system
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)