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Oculo-Plastik Inc

Last updated May 24, 2026

What Oculo-Plastik Inc makes

Oculo-Plastik Inc manufactures ophthalmic devices including radiation/mechanical corneal shields, epiocular radiation shields, ophthalmic conformers, orbital sphere implant sizers, hand-held surgical retractors, corneal shield applicators, and symblepharon rings. Their specific products include Plastic Jaeger lid plates, Sutcliffe SS Shield & Retractor, Bilateral Conformers, Durette® series, Enucleation/Evisceration Sizer, Symblepharon Ring Conformer, and Autoclavable Plastic Ocular Shields.

The company's portfolio is regulated under Class I and Class II device categories and is listed in the FDA 510(k) and FDA UDI registries. Oculo-Plastik Inc is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: oculoplastik.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 514-381-3292
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 257382580

Catalogue (288)

Page 3 of 6

Device	Model / Reference	Registries	Class	Status
Durette® II, SS External Ocular Laser Shields, regular (non glare)	21-335	FDA UDI	Class I	Active
Durette #4, PMMA (20 mm, 3.5 cc)	12-420	FDA UDI	Class II	Unknown
OPSoft® Mouthguards for laser (1 unit)	60-104S	FDA UDI	Class I	Active
Cox® II, SS Ocular Laser Shield, x-small (non glare), refurb.	21-261RE	FDA UDI	Class I	Unknown
Castroviejo Suturing Forceps (0.3 mm), refurb.	25-103R	FDA UDI	Class I	Unknown
Desmarres (16 mm) Stainless Steel Retractor for Laser (non glare)	21-316	FDA UDI	Class I	Unknown
Acrylic Spheres 20 mm, 3.6 cc	11-320	FDA UDI	Class II	Unknown
Bilateral Conformer 18 Regular, In Bulk	19-114V	FDA UDI	Class II	Unknown
Durette® II, SS External Ocular Laser Shields, regular (non glare), repaired	21-335S	FDA UDI	Class I	Unknown
Sutcliffe Boey SS Laser Shield with all holes in one (non glare)	21-287	FDA UDI	Class I	Active
Cox® II, SS Ocular Laser Shield, left, small (non glare) w. handle	21-262HLE	FDA UDI	Class I	Unknown
Replacement SS attachments for Durette® IV (temporals only) (2 units)	21-550T	FDA UDI	Class I	Active
Cox® II, SS Ocular Laser Shield, right, large (non glare) w. handle	21-266HR	EUDAMEDFDA UDI	Class I	Active
Silicone Spheres (20 mm, 4.2 cc)	11-220	FDA UDI	Class II	Unknown
Desmarres (12 mm) Stainless Steel Retractor for Laser (non glare)	21-312	FDA UDI	Class I	Unknown
Bilateral Conformer 22 Small, In Bulk	19-092V	FDA UDI	Class II	Unknown
Knap Stainless Steel Retractor for Laser (non glare)	28-010	FDA UDI	Class I	Unknown
Desmarres, Autoclavable plastic retractor t-yellow	23-315Y	FDA UDI	Class I	Unknown
Skin Hook Retractor (with 2 Sharp Prongs) (non glare)	28-012	FDA UDI	Class I	Unknown
Autoclavable Plastic Ocular Shield, bilateral, large, black, with handle	23-206BH	EUDAMEDFDA UDI	Class I	Active
Adson Stainless Steel Laser Forceps (1x2 teeth) (non glare)	25-226	FDA UDI	Class I	Unknown
Bilateral Conformer 22 Regular With Holes	19-094T	FDA UDI	Class II	Active
Autoclavable Plastic Ocular Shield, bilateral, extra-small, t-yellow	23-201YE	FDA UDI	Class I	Unknown
Fomon Ball Stainless Steel Retractor for Laser (non glare)	21-319	FDA UDI	Class I	Unknown
Knap Stainless Steel Retractor for Laser (non glare), refurb.	28-010R	FDA UDI	Class I	Unknown
Silicone Spheres (16 mm, 2.1 cc)	11-216	FDA UDI	Class II	Unknown
Symblepharon Ring Conformer Medium	21-414	FDA UDI	Class II	Unknown
Acrylic Spheres 16 mm, 2.1 cc	11-316	FDA UDI	Class II	Unknown
Bilateral Conformer 22 Small With Holes	19-092T	FDA UDI	Class II	Unknown
Enucleation/Evisceration Sizers (set)	A1-SET	FDA UDI	Class I	Active
Silicone Spheres (15 mm, 1.8 cc)	11-215	FDA UDI	Class II	Unknown
Symblepharon Ring Conformer Medium, In Bulk	21-414V	FDA UDI	Class II	Unknown
Bilateral Conformer 18 Regular	19-114	FDA UDI	Class II	Active
Acrylic Spheres 12 mm, 1.1 cc	11-312	FDA UDI	Class II	Unknown
Replacement SS attachments for Durette® IV (set of 4)	21-550	FDA UDI	Class I	Active
Bilateral Conformer 22 Small With Holes, Bulk	19-092TV	FDA UDI	Class II	Unknown
Bilateral Conformers 22 Extra-Small	19-091	FDA UDI	Class II	Active
Autoclavable Plastic Ocular Shield, bilateral, x-small, t-yellow, with handle	23-201YHE	FDA UDI	Class I	Unknown
Replacement SS attachments for Durette® IV (nasals only) (2 units)	21-550N	FDA UDI	Class I	Active
Bilateral Conformer 18/20 Small, In Bulk	19-102V	FDA UDI	Class II	Unknown
Autoclavable Plastic Ocular Shield, bilateral, extra-small, black	23-201BE	FDA UDI	Class I	Unknown
Castroviejo Suturing Forceps (0.3 mm)	25-103	FDA UDI	Class I	Unknown
Desmarres (18 mm) Stainless Steel Retractor for Laser (non glare)	21-318	FDA UDI	Class I	Unknown
Bilateral Conformer 18/20 Regular	19-104	FDA UDI	Class II	Unknown
Silicone Spheres (19 mm, 3.6 cc)	11-219	FDA UDI	Class II	Unknown
Cox® II, SS Ocular Laser Shield, x-small (non glare) w. suction cup	21-261	FDA UDI	Class I	Active
Autoclavable Plastic Ocular Shield, bilateral, small, black	23-202BE	FDA UDI	Class I	Unknown
Silicone Spheres (15 mm, 1.8 cc) In Bulk	11-215V	FDA UDI	Class II	Unknown
Durette #1, PMMA (20 mm, 4.0 cc)	12-120	FDA UDI	Class II	Unknown
Cox® II, SS Ocular Laser Shield, left, small (non glare) w. handle	21-262HL	EUDAMEDFDA UDI	Class I	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Oculo Plastik, Inc. MONTREAL Quebec · CA FEI 3002513507