Surgical Direct

Basic Information

• Brand Name: Surgical Direct
• Primary DI: B382S348431000
• Version / Model: S34843.100
• Catalog Number: S34843.100
• Company Name: Surgical Direct, Inc.
• Labeler DUNS: 124367223
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-26
• Public Version: 1
• Public Version Date: 2023-05-04
• Public Version Status: New
• Public Device Record Key: 909c2eac-773b-4e5c-b1c6-15d6eb133fa3

Device Description

4 3/4 inch Sharvelle Style Sideport Nucleus Splitter Angled 45° 8mm Bend To Y Shaped

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
63431	Intraocular retractor, reusable	A dedicated ophthalmic surgical instrument intended to be used explicitly for the temporary mechanical retraction/dilatation of intraocular tissues (e.g., iris) during ophthalmic surgery. It is typically a small hook-like device which may include a retention bead or a self-retaining ring/frame, and is designed to be manipulated using another ophthalmic instrument; it is not a hand-held ophthalmic hook. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B382S348431000	HIBCC

Customer Contacts

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