Amimon

Basic Information

• Brand Name: Amimon
• Primary DI: 00860014100680
• Version / Model: HM11 Device - MDWL1_HM11
• Catalog Number: MDWL1_HM11
• 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: aa9fcb7e-50b8-4f6a-bea4-f41dfa3c11ee

Device Description

HM11 Device

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	886.4335	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46807	Head-worn lamp	An electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860014100680	GS1