WALCOTT RX PRODUCTS

Basic Information

• Brand Name: WALCOTT RX PRODUCTS
• Primary DI: 00385640067249
• Version / Model: RX90910
• Company Name: Summit Medical, Inc.
• Labeler DUNS: 965484699
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-20
• Public Version: 1
• Public Version Date: 2022-12-28
• Public Version Status: New
• Public Device Record Key: 3525597f-1059-4994-acf0-90f5252c49f6

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HOZ	Sponge, Ophthalmic	Ophthalmic	886.4790	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61965	Medical device cleaning sponge/set	A hand-held manual device in the form of a soft or abrasive sponge/pad, sometimes with non-medicated substances (e.g., enzymes, surfactant) and potentially other related items (e.g., receptacle), intended to be used for the pre-cleaning (i.e., removal of gross blood and other organic debris) of medical devices prior to disinfection or sterilization; it is not intended for use during a medical/surgical procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10385640067246	GS1	Box	20	In Commercial Distribution
Primary	00385640067249	GS1