FDA Registration
Active
🇺🇸 United States
SMART PRACTICE
Reg #: 2083595
·
FEI: 2083595
·
Expires 2026
Products
8
Proprietary Names
7
Establishment Types
4
Classifications
8
Registration Details
- Registration Name
- SMART PRACTICE
- Registration Number
- 2083595
- FEI Number
- 2083595
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3400 EAST MCDOWELL RD.
- City
- PHOENIX
- State
- AZ
- ZIP
- 85008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063160
Owner / Operator
- Firm Name
- SMART PRACTICE
- Operator Number
- 2083595
- Address
- 3400 EAST MCDOWELL RD., --
- City
- Phoenix
- State
- AZ
- Postal Code
- 85008
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2007-02-12 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | Class 1 | Clinical Chemistry | No | 2020-11-03 |
| System, Suspension, Cell Culture | KJF | Class 1 | Hematology | No | 2022-02-15 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2020-11-03 |
| Flask, Tissue Culture | KJA | Class 1 | Hematology | No | 2023-05-24 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2020-11-03 |
| Tissue Culture, Accessories, Dental | NVG | Class 1 | Hematology | No | 2021-05-27 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2020-11-03 |
Proprietary Names
allergEAZE
Finn Chambers Aqua
Finn Chamber FLAT PATCH
allergEAZE clear
patchProtect
Finn Chambers
SmartPractice Skin Marker
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility