| Primary Device ID | 00850025993982 |
| NIH Device Record Key | 8ad06313-ea25-4ace-81d3-d787488cfab9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enova Illumination |
| Version Model Number | 80305-001 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00850025993982 [Primary] |
| HPP | Headlamp, Operating, Battery-Operated |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-06 |
| Device Publish Date | 2024-10-29 |
| 00850025993241 | Deluxe comfort pad set (Quantum) w/ Stryker Branding - 10 Pack |
| 00850025993234 | Standard Comfort Pad (Quasar) w/ Stryker Branding - 10 Pack |
| 00850025993227 | Deluxe comfort pad set (Quantum) w/ Stryker Branding - 3 Pack |
| 00850025993210 | Standard Comfort Pad (Quasar) w/ Stryker Branding - 3 Pack |
| 00850025993203 | Stryker Black DRH w/ Occip Quantum Warm Surgical Headlight |
| 00850025993197 | Stryker Black SRH Quasar Cool LED Surgical Headlight |
| 00850025993180 | Stryker Black SRH Quasar Warm Surgical Headlight |
| 00850025993173 | Stryker Black DRH w/ Occip Quantum Cool Surgical Headlight |
| 00850025993166 | Gray Twist Cable (Quantum) w/ Stryker Branding |
| 00850025993159 | Stryker Power Pack Base Station w/ C13 Power Cord |
| 00850025993142 | Black Extension Cable (Quasar) w/ Stryker Branding |
| 00850025993135 | NA C-13 Power Cord for Power Pack Base Station - Stryker |
| 00850025993128 | Battery Belt - Stryker |
| 00850025993111 | Occipital Comfort Pad (Quantum) w/ Stryker Bag |
| 00850025993104 | Standard comfort pad set (Quasar) w/ Stryker Bag |
| 00850025993098 | Stryker Composite Carrying Case |
| 00850025993081 | Deluxe comfort pad set (Quantum) w/ Stryker Bag |
| 00850025993074 | Occipital Mesh Replacement - w/ Stryker Bag |
| 00850025993067 | Black DRH w/ Occip Support and attached bracket w/ Stryker Bag |
| 00850025993050 | Black SRH and attached bracket w/ Stryker Bag |
| 00850025993005 | Stryker PP4 Power Pack |
| 00850025993272 | Clip-on LED Light System with Battery Accessories |
| 00850025993265 | Surgical Loupes |
| 00850025993258 | LED Surgical Headlight Mounted on Headband with Battery Accessories |
| 00850025993746 | European Power Cord – C13 |
| 00850025993739 | North American Power Cord – C13 |
| 00850025993722 | Battery Belt |
| 00850025993715 | Black Snap Cable |
| 00850025993708 | Black Extension Cable |
| 00850025993692 | Grey Twist Battery Cable |
| 00850025993685 | Black Twist Battery Cable |
| 00850025993678 | Composite Carrying Case |
| 00850025993661 | Extra Large Soft-Sided Case |
| 00850025993654 | Soft-Sided Case |
| 00850025993647 | Power Pack Base Station |
| 00850025993630 | FS3 Battery Charger |
| 00850025993623 | PP Single Battery Charger |
| 00850025993616 | PP4 – Power Pack |
| 00850025993609 | PP2 – Power Pack |
| 00850025993593 | PP1.5 Power Pack |
| 00850025993586 | FS3 – FreeStyle |
| 00850025993579 | Quantum Warm/PLT-175A LED Surgical Light |
| 00850025993562 | PLT-165A LED Surgical Light |
| 00850025993555 | Quasar Warm/PLT-115A LED Surgical Light |
| 00850025993548 | PLT-100A LED Surgical Light |
| 00850025993531 | Qubit Warm/PLT-80F LED Surgical Light |
| 00850025993524 | PLT-60F LED Surgical Light |
| 00850025993517 | PLT-ENT LED Surgical Light |
| 00850025993500 | Quantum Cool/XLT-250A LED Surgical Light |
| 00850025993494 | XLT-225A LED Surgical Light |