FDA Registration
Active
🇨🇦 Canada
OCULO PLASTIK, INC.
Reg #: 8022166
·
FEI: 3002513507
·
Expires 2026
Products
9
Proprietary Names
16
Establishment Types
3
Classifications
9
Registration Details
- Registration Name
- OCULO PLASTIK, INC.
- Registration Number
- 8022166
- FEI Number
- 3002513507
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 200 SAUVE WEST
- City
- MONTREAL Quebec
- Country
- CA
Owner / Operator
- Firm Name
- GESTION BOUCHER/DURETTE
- Operator Number
- 8022167
- Address
- 1170 HENRI-BOURASSA EAST, --
- City
- MONTREAL
- State
- Quebec
- Postal Code
- H2C 1G4
- Country
- CA
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Jerry Doane
- Address
- 15815 SW 11th Court Rd
- City
- Ocala
- State
- FL
- ZIP
- 34473
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2015-06-11 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2000-10-30 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1998-04-29 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 1996-11-27 |
| Inserter/Remover Contact Lens | KYE | Class 1 | Ophthalmic | No | 1998-04-29 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2000-08-23 |
| Shield, Eye, Radiological | IWS | Class 1 | Radiology | No | 2005-10-04 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 1997-03-26 |
| Conformer, Ophthalmic | HQN | Class 2 | Ophthalmic | No | 1987-09-03 |
Proprietary Names
Hard Inlay Wax
DAVID-BAKER LID CLAMP
SIZERS
COX OCULAR LASER SHIELD
PLASTIC OCULAR SHIELD
Anesthesia Eye Patch; Derm Eye Patch; IPL Patch; Laser Eye Patch
NONE (SUCTION CUPS)
JAEGER
SUTCLIFFE
KHAN-JAEGER
PLASTIC DURETTE
DURETTE EXTERNAL SHIELDS
LASERSHIELDS
OPSoft Mouthguard
CONFORMER
SYMBLEPHARON RINGS
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device