Wexler Surgical, Inc.

Basic Information

• Brand Name: Wexler Surgical, Inc.
• Primary DI: M944BL000440
• Version / Model: BL0004.4
• Company Name: WEXLER SURGICAL, INC.
• Labeler DUNS: 024882552
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-02
• Public Version: 2
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: b87d4f8c-08ac-49fd-bdcd-637e055f6b5c

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
OHW	Burr, Corneal, Battery Powered, Rust Ring Removal	Ophthalmic	886.4070	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46395	Corneal bur handpiece, battery-powered	A battery-powered, hand-held rotating device designed to perform corneal, and other ophthalmic tissue, abrasion through a bur attached to its distal tip. The device typically stops if the pressure on the tissue (e.g., cornea) is beyond a pre-established limit. It is used (with appropriate burs) to clean rust rings from the cornea after the extraction of a ferrous foreign object, to polish corneal scratches and/or the pterygium bed after surgical removal, and/or for abrasion of lid margin lesions. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M944BL000440	HIBCC
Secondary	00840240911335	GS1