FDA Registration
Active
🇺🇸 United States
PARKER LABORATORIES, INC.
Reg #: 2212018
·
FEI: 2212018
·
Expires 2026
Products
9
Proprietary Names
29
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- PARKER LABORATORIES, INC.
- Registration Number
- 2212018
- FEI Number
- 2212018
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 286 ELDRIDGE RD.
- City
- FAIRFIELD
- State
- NJ
- ZIP
- 07004
- Country
- US
Regulatory Submissions
- 510(k) Number
- K864556
Owner / Operator
- Firm Name
- PARKER LABORATORIES, INC.
- Operator Number
- 2212018
- Address
- 286 ELDRIDGE RD., --
- City
- Fairfield
- State
- NJ
- Postal Code
- 07004
- Country
- US
- Correspondent
- NEAL - BUCHALTER
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lubricant, Patient | KMJ | Class 1 | General Hospital | No | 2008-02-06 |
| Media, Coupling, Ultrasound | MUI | Class 2 | Radiology | No | 2014-11-14 |
| Media, Electroconductive | GYB | Class 2 | Neurology | No | 2008-02-07 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2008-02-07 |
| Foam Or Gel Chemical Sterilant/High Level Disinfectant | QWS | Class 2 | General Hospital | No | 2023-09-22 |
| Apparatus, Electrosurgical | HAM | Class 2 | General, Plastic Surgery | No | 2020-01-22 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2020-01-22 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2017-06-21 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2017-06-12 |
Proprietary Names
Aquagel Lubricating Gel
Timm Medical Lubricating Gel
Polysonic Ultrasound Lotion
Spectra 360 Electrode Gel
Redux Electrolyte
Signagel Electrode Gel
Gammacore Electrode Gel
Brainscope Skin Prep Gel
Eclipse Probe Cover
Aquasonic 100 Sterile
Scan
Aquasonic 100
Aquasonic Clear
Medvat Clear Unscented Ultrasonic Gel with Aloe Vera
Tristel ULT
Signaspray
Signapad
Rebuilder Medical Electrolyte
Innovo Spray Electrode Solution and Skin Prep
Alpha-Stim Conductive Solution
Ultradrape
Ultradrape II
Signacreme
BioWrap Conductive Cream
Pulsetto Conductive Gel
Grass EC3 Conductive Adhesive Gel
Tensive Conductive Adhesive Gel
Aquaflex
Delphinus Sequr Breast Interface
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)