GUDID 00850025993791

Quantum Warm XL LED Surgical Headlight

Enova Illumination, Inc.

Head-worn lamp

• Primary Device ID: 00850025993791
• NIH Device Record Key: aac89e34-6a26-400f-8087-559428ffca03
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 5460-700-046
• 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: false
• 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	00850025993791 [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: 2022-07-06
• Device Publish Date: 2022-06-28

Devices Manufactured by Enova Illumination, Inc.

• 00850025993968 - Enova Illumination: 2024-11-06 Quest LED Surgical Headlight
• 00850025993975 - Enova Illumination: 2024-11-06 PP4+ - Power Pack
• 00850025993982 - Enova Illumination: 2024-11-06 PP4+ Battery Cable - ENOVA
• 00850025993944 - QOSMIC: 2023-09-05 QOSMIC™ LED Headlight Only SRO
• 00850025993951 - QOSMIC: 2023-09-05 QOSMIC™ SRO Replacement Pad Set
• 00850025993852 - QOSMIC: 2023-08-21 QOSMIC™ LED Headlight Only DRO
• 00850025993869 - QOSMIC: 2023-08-21 QOSMIC™ LED Headlight Only DR
• 00850025993876 - QOSMIC: 2023-08-21 QOSMIC™ LED Headlight Only SR