Primary Device ID | 00850025993234 |
NIH Device Record Key | cf4e3d86-51dd-45f3-b86f-a1712e68a929 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Enova Illumination |
Version Model Number | 5460-700-033 |
Catalog Number | 5460-700-033 |
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 |
Phone | 13135597444 |
jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
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jward@goenova.com | |
Phone | 13135597444 |
jward@goenova.com | |
Phone | 13135597444 |
jward@goenova.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850025993234 [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 | 2021-01-21 |
Device Publish Date | 2021-01-13 |
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 |