QOSMIC

GUDID 00850025993906

QOSMIC™ DRO Replacement Pad Set

Enova Illumination, Inc.

Head-worn lamp

• Primary Device ID: 00850025993906
• NIH Device Record Key: 2a7e603b-aed8-4f71-a4a7-1b5b5d5e1098
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QOSMIC
• Version Model Number: 5460-800-009
• Company DUNS: 080805136
• Company Name: Enova Illumination, Inc.
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	00850025993906 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-21
• Device Publish Date: 2023-08-11

On-Brand Devices [QOSMIC]

• 00850025993937: Single Battery Charger
• 00850025993920: QOSMIC™ SR Replacement Pad Set
• 00850025993913: QOSMIC™ DR Replacement Pad Set
• 00850025993906: QOSMIC™ DRO Replacement Pad Set
• 00850025993890: QOSMIC™ Twist Cable
• 00850025993883: QOSMIC™ Battery Pack
• 00850025993876: QOSMIC™ LED Headlight Only SR
• 00850025993869: QOSMIC™ LED Headlight Only DR
• 00850025993852: QOSMIC™ LED Headlight Only DRO
• 00850025993951: QOSMIC™ SRO Replacement Pad Set
• 00850025993944: QOSMIC™ LED Headlight Only SRO