PRK, LASIK, LASEK, IntraLasik and Flap Management Instruments

Basic Information

• Brand Name: PRK, LASIK, LASEK, IntraLasik and Flap Management Instruments
• Primary DI: 08175700110747
• Version / Model: AS3-632
• Catalog Number: AS3-632
• Company Name: AURORA SURGICAL, LLC
• Labeler DUNS: 968368832
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-11
• Public Version: 1
• Public Version Date: 2024-07-19
• Public Version Status: New
• Public Device Record Key: 3f83fd30-a4a6-493d-9244-dac12c56f1c8

Device Description

MacRae Flap Flipper, DBL-Ended, Spatula is .9mm wide, Angled 10mm from bend to tip / V-shaped tip .8mm wide Angled 9.5mm from bend to tip with sharp inner edges, Round Knurled Handle, 132mm Overall Length, Stainless Steel

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: No
• 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
HND	Spatula, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13120	Ophthalmic surgical probe, reusable	A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08175700110747	GS1

Customer Contacts

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