Optizyme

Basic Information

• Brand Name: Optizyme
• Primary DI: H816OP1281
• Version / Model: OP128
• Catalog Number: OP128
• Company Name: MicroCare, LLC
• Labeler DUNS: 118518186
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-23
• Public Version: 1
• Public Version Date: 2025-10-31
• Public Version Status: New
• Public Device Record Key: 1396ac7b-cc5a-494c-b163-6efc8ce96848

Device Description

Enzymatic Detergent

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	880.6150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63385	Medical device cleaning agent	A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	OP1282	HIBCC	Case Box	4	In Commercial Distribution
Primary	H816OP1281	HIBCC