Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8022166

FEI Number

3002513507

Entity Name

OCULO PLASTIK, INC.

City/State/Country

MONTREAL Quebec, CA

Establishment Address

200 SAUVE WEST, MONTREAL Quebec H3L 1Y9, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GESTION BOUCHER/DURETTE (Owner Number: 8022167)

Owner / Operator Contact Address

1170 HENRI-BOURASSA EAST, --, MONTREAL, CA-QC H2C 1G4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2015-06-11
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2000-10-30
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	1998-04-29
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	1996-11-27
KYE	Inserter/Remover Contact Lens	Ophthalmic	Class 1	886.5420	1998-04-29
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2000-08-23
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	2005-10-04
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	1997-03-26

Official Correspondent

No official correspondent registered.

US Agent Details

Jerry Doane Business: Pragmatic Compliance dba FDAbasics Email: usagent@fdabasics.com Phone: (716) 7750533

Related Public Records

Same Entity

GESTION BOUCHER/DURETTE

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
3001122163	KENT MANUFACTURING COMPANY	Grand Rapids, MI, US
3009426332	GARRECO, LLC	Heber Springs, AR, US
1821514	KULZER, LLC	SOUTH BEND, IN, US
3004623350	ASHTEL STUDIOS, INC.	Ontario, CA, US
3022519816	SHENZHEN YONGCHANGHE TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8022166. Last updated year: 2026. Please use registration number 8022166 when referencing this establishment in official correspondence.