Sutcliffe Boey SS Laser Shield with all holes in one (non glare)

FDA UDI

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name: Sutcliffe Boey SS Laser Shield with all holes in one (non glare) FDA UDI
Generic Name: Hand-held surgical retractor, reusable FDA UDI
Device Name: The Sutcliffe Boey is an instrument to treat cutaneous lesions (freckles, etc) during laser procedures. The holes limit the size of the laser beam and serve to isolate various sizes of the skin's section according to the need. Holes' sizes are: 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, and 7mm. FDA UDI
Model / Reference: 21-287 FDA UDI
Description: The Sutcliffe Boey is an instrument to treat cutaneous lesions (freckles, etc) during laser procedures. The holes limit the size of the laser beam and serve to isolate various sizes of the skin's section according to the need. Holes' sizes are: 1mm, 2mm, 3mm, 4mm, 5mm, 6mm, and 7mm. FDA UDI

Identifiers

Primary DI / UDI-DI: 10697660001958 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Hand-held surgical retractor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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Implantable

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Contains Latex

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Prescription Use

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Over-the-Counter

FDA UDI

Convenience Kit

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Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

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Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Lumen/Inner Diameter — 7 Millimeter FDA UDI
Lumen/Inner Diameter — 6 Millimeter FDA UDI
Lumen/Inner Diameter — 5 Millimeter FDA UDI
Lumen/Inner Diameter — 4 Millimeter FDA UDI
Lumen/Inner Diameter — 3 Millimeter FDA UDI
Lumen/Inner Diameter — 2 Millimeter FDA UDI
Lumen/Inner Diameter — 1 Millimeter FDA UDI

Category: Hand-held surgical retractor, reusable

Sutcliffe Boey SS Laser Shield with all holes in one (non glare) by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Oculo-Plastik Inc

Sources (1)

FDA UDI e48ece7a-d309-4eaf-abab-5e5584b7f6b4 35 fields · synced May 30, 2026