Walcott Rx Products

Basic Information

• Brand Name: Walcott Rx Products
• Primary DI: 00840516135175
• Version / Model: Rx117
• Company Name: Psi/Eye-Ko, Inc.
• Labeler DUNS: 063763833
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-18
• Public Version: 1
• Public Version Date: 2023-08-28
• Public Version Status: New
• Public Device Record Key: 31198894-6427-48e1-94a3-92bd11b244f4

Device Description

[Barraquer] Eye Speculum Child

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: 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: 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
Package	00840516135427	GS1	Bag	50	In Commercial Distribution
Primary	00840516135175	GS1
Package	00840516135656	GS1	Bag	500	In Commercial Distribution

Customer Contacts

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