Walcott Rx Products

Basic Information

• Brand Name: Walcott Rx Products
• Primary DI: 00840285312975
• Version / Model: Rx103S
• Company Name: Walcott Rx Product Inc
• Labeler DUNS: 837689694
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-10
• Public Version: 1
• Public Version Date: 2022-08-18
• Public Version Status: New
• Public Device Record Key: 448404e2-b42b-49fd-b9e9-5b04058a45f0

Device Description

Speculum

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: Yes
• 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
HNC	Specula, ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35349	Eyelid speculum, reusable	A self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic 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 and is usually made of stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840285312975	GS1

Customer Contacts

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