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Sutcliffe Boey SS Laser Shield with all holes in one (non glare), refurb.
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Sutcliffe Boey SS Laser Shield with all holes in one (non glare), refurb. 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
- 21-287R 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
- 10697660001965 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
- Not 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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 1 Millimeter FDA UDILumen/Inner Diameter — 2 Millimeter FDA UDILumen/Inner Diameter — 3 Millimeter FDA UDILumen/Inner Diameter — 4 Millimeter FDA UDILumen/Inner Diameter — 5 Millimeter FDA UDILumen/Inner Diameter — 6 Millimeter FDA UDILumen/Inner Diameter — 7 Millimeter FDA UDI
Sutcliffe Boey SS Laser Shield with all holes in one (non glare), refurb. by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID
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 c8da93b5-d50e-49dd-838d-34e667468621 36 fields · synced Jun 1, 2026