Amimon

Basic Information

• Brand Name: Amimon
• Primary DI: 00860014100659
• Version / Model: SL11 Sterilizable Cover - AMN_ASM_1030
• Catalog Number: AMN_ASM_1030
• Company Name: Rocoto Inc.
• Labeler DUNS: 960475866
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-24
• Public Version: 2
• Public Version Date: 2026-01-29
• Public Version Status: Update
• Public Device Record Key: d4b3a4ea-1346-464e-8670-aa64adf62dd9

Device Description

SL11 Sterilizable Cover

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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44975	Medical equipment handle cover, reusable	A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a rigid polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860014100659	GS1