Amimon MDWL1_HM11

GUDID 00860014100680

HM11 Device

Rocoto Inc.

Head-worn lamp

• Primary Device ID: 00860014100680
• NIH Device Record Key: aa9fcb7e-50b8-4f6a-bea4-f41dfa3c11ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Amimon
• Version Model Number: HM11 Device - MDWL1_HM11
• Catalog Number: MDWL1_HM11
• Company DUNS: 960475866
• Company Name: Rocoto Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860014100680 [Primary]

FDA Product Code

• HPP: Headlamp, Operating, Battery-Operated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-01-29
• Device Publish Date: 2025-06-24

On-Brand Devices [Amimon]

• 00860014100680: HM11 Device
• 00860014100673: MD52 Rx device
• 00860014100666: MD52 Tx device
• 00860014100659: SL11 Sterilizable Cover
• 00860014100642: SL11 device
• 00860014100635: MD11 Rx device
• 00860014100628: MD11 Tx device
• 00860014100611: MD62 Rx device
• 00860014100604: MD62 Tx device