FDA Registration
Active
🇺🇸 United States
INTUIT MEDICAL PRODUCTS, LLC
Reg #: 3012422952
·
FEI: 3012422952
·
Expires 2026
Products
4
Proprietary Names
4
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- INTUIT MEDICAL PRODUCTS, LLC
- Registration Number
- 3012422952
- FEI Number
- 3012422952
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1990 Riverside Parkway
- City
- Lawrenceville
- State
- GA
- ZIP
- 30043
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143738
Owner / Operator
- Firm Name
- Intuit Medical Products, LLC
- Operator Number
- 10050055
- Address
- 1990 Riverside Parkway
- City
- Lawrenceville
- State
- GA
- Postal Code
- 30043
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 2021-01-06 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2015-10-08 |
| Forceps, Ent | KAE | Class 1 | Ear, Nose, Throat | No | 2021-01-06 |
| Bronchoscope Accessory | KTI | Class 2 | Ear, Nose, Throat | No | 2017-12-26 |
Proprietary Names
ClearPath Nasal Balloon System
ClearPath Nasal Balloon Guide Spatula
Dillard Airway Balloon Catheter
ClearPath Nasal Balloon Catheter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device