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Sutcliffe SS Shield & Retractor for the Laser (flat) (non glare)

FDA UDI

Class I (US FDA UDI)

by Oculo-Plastik Inc

Identity

Trade Name
Sutcliffe SS Shield & Retractor for the Laser (flat) (non glare) FDA UDI
Generic Name
Hand-held surgical retractor, reusable FDA UDI
Device Name
The SUTCLIFFE shields, with all surfaces nonreflective for safe use with the laser, come in many configurations for various applications. The same basic piece is available modified in design to shield different parts of the body. You can shield eyelashes, eyebrows, eyelids, freckles, lips, gums, teeth, etc. and any tissue (deep or superficial) needing protection. Useful during skin resurfacing, incisional procedures, skin depigmentation, etc. In surgery, they can serve as an instrument for retracting tissue and as a backstop. You will discover many uses for it. The bent model is easier to pick up when gloved. FDA UDI
Model / Reference
21-275 FDA UDI
Description
The SUTCLIFFE shields, with all surfaces nonreflective for safe use with the laser, come in many configurations for various applications. The same basic piece is available modified in design to shield different parts of the body. You can shield eyelashes, eyebrows, eyelids, freckles, lips, gums, teeth, etc. and any tissue (deep or superficial) needing protection. Useful during skin resurfacing, incisional procedures, skin depigmentation, etc. In surgery, they can serve as an instrument for retracting tissue and as a backstop. You will discover many uses for it. The bent model is easier to pick up when gloved. FDA UDI

Identifiers

Primary DI / UDI-DI
10697660001897 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Hand-held surgical retractor, reusable

Sutcliffe SS Shield & Retractor for the Laser (flat) (non glare) by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand-held surgical retractor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Oculo-Plastik Inc

Sources (1)

  • FDA UDI 7c7f4a77-31f5-4bc1-98ab-c8a1eb63372d 34 fields · synced May 30, 2026