FDA Registration
Active
🇺🇸 United States
Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
Reg #: 1317188
·
FEI: 1317188
·
Expires 2026
Products
11
Proprietary Names
25
Establishment Types
6
Classifications
11
Registration Details
- Registration Name
- Graphic Controls Acquisition Corp.dba Nissha Medical Technologies
- Registration Number
- 1317188
- FEI Number
- 1317188
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 400 Exchange St
- City
- BUFFALO
- State
- NY
- ZIP
- 14204
- Country
- US
Regulatory Submissions
- 510(k) Number
- K010638
- PMA Number
- P200007
Owner / Operator
- Firm Name
- Nissha Medical Technologies
- Operator Number
- 9106359
- Address
- 400 EXCHANGE STREET, --
- City
- Buffalo
- State
- NY
- Postal Code
- 14204
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2023-12-19 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2016-02-13 |
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2021-02-22 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2023-11-22 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2018-01-18 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2022-02-17 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2023-12-19 |
| Dc-Defibrillator, Low-Energy, (Including Paddles) | LDD | Class 2 | Cardiovascular | No | 2016-08-10 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2018-02-27 |
| Prosthesis, Nose, Internal | FZE | Class 2 | General, Plastic Surgery | No | 2023-12-20 |
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2016-02-13 |
Proprietary Names
NeuroPlus
Philips Connector Heartsync Multifunction Disposable Single Use AED Defibirllator Pads
HEART SYNC PEDIATRIC, MODEL PED-100
Heartsync Multifunction Disposable Single-Use AED Defibrillator Pads
Graphic Controls Ultra Film
1410500 Adult Solid Gel Tape Electrode
Swaromed
Z-Brand
SofTouch
SilveRest
VersaTrode
Lead-Lok
BluFlex
V-Series
EMS Electrodes
TenderTrode Plus
PhysioFlow
PNS Electrodes
ClearScan
Guardian
Performance Plus
TenderTrode
Regal
SimplySnap
NeuroPlus Multipurpose Electrodes (A10005)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198