FDA Registration
Active
🇺🇸 United States
VISCOT MEDICAL LLC
Reg #: 2242656
·
FEI: 2242656
·
Expires 2026
Products
17
Proprietary Names
12
Establishment Types
3
Classifications
17
Registration Details
- Registration Name
- VISCOT MEDICAL LLC
- Registration Number
- 2242656
- FEI Number
- 2242656
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 32 WEST ST.
- City
- EAST HANOVER
- State
- NJ
- ZIP
- 07936
- Country
- US
Regulatory Submissions
- 510(k) Number
- K935932
Owner / Operator
- Firm Name
- VISCOT MEDICAL LLC
- Operator Number
- 9068829
- Address
- 32 WEST ST.
- City
- East Hanover
- State
- NJ
- Postal Code
- 07936
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauze/Sponge, Internal | EFQ | Class U | Unknown | No | 2023-11-08 |
| Label Or Tag, Sterile | LYV | Class 1 | General, Plastic Surgery | No | 2006-02-23 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2023-11-08 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2023-11-08 |
| Dissector, Tonsil | KBM | Class 1 | Ear, Nose, Throat | No | 2023-11-08 |
| Label Or Tag, Non-Sterile | QMX | Class 1 | General, Plastic Surgery | No | 2023-11-29 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 1992-07-06 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2019-06-20 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2023-11-08 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2012-04-16 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 1992-07-06 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 2023-11-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2006-02-23 |
| Urinal | FNP | Class 1 | General Hospital | No | 2006-02-23 |
| Pen, Marking, Surgical | HRP | Class 1 | Ophthalmic | No | 2023-11-08 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2023-11-08 |
| Wrap, Sterilization | FRG | Class 2 | General Hospital | No | 2020-03-04 |
Proprietary Names
O.R. MEDICATION MARKING KIT
Dukal
20307
Viscot
TWENTY-FOUR HOUR C
VisDrape
Vismark Medication Label Kit with Waterproof Marker
ViXL Ink
VISMARK SURGICAL SKIN MARKER
R-24
MILLIE FEMALE URINAL
Tormark
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)