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

Basic Information

• Brand Name: Sutcliffe Boey SS Laser Shield with all holes in one (non glare)
• Primary DI: 10697660001958
• Version / Model: 21-287
• Company Name: Oculo-Plastik Inc
• Labeler DUNS: 257382580
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-21
• Public Version: 1
• Public Version Date: 2019-11-29
• Public Version Status: New
• Public Device Record Key: e48ece7a-d309-4eaf-abab-5e5584b7f6b4

Device 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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GAD	Retractor	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45918	Hand-held surgical retractor, reusable	A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10697660001958	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	7	Millimeter
Lumen/Inner Diameter	6	Millimeter
Lumen/Inner Diameter	5	Millimeter
Lumen/Inner Diameter	4	Millimeter
Lumen/Inner Diameter	3	Millimeter
Lumen/Inner Diameter	2	Millimeter
Lumen/Inner Diameter	1	Millimeter