Anodyne Surgical

Basic Information

• Brand Name: Anodyne Surgical
• Primary DI: 00840516127804
• Version / Model: 8405
• Company Name: Psi/Eye-Ko, Inc.
• Labeler DUNS: 063763833
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-08-02
• Public Version: 1
• Public Version Date: 2023-08-10
• Public Version Status: New
• Public Device Record Key: 9dfaefa5-efae-4144-808b-0857f8b1056d

Device Description

[Barraquer] Wire Speculum (w/ Tabs)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HNC	Specula, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46959	Eyelid speculum, single-use	A self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00840516126746	GS1
Primary	00840516127804	GS1

Customer Contacts

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