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

Basic Information

• Brand Name: Sutcliffe SS Shield & Retractor for the Laser (flat) (non glare)
• Primary DI: 10697660001897
• Version / Model: 21-275
• 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: 7c7f4a77-31f5-4bc1-98ab-c8a1eb63372d

Device 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.

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	10697660001897	GS1

Customer Contacts

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