Enova Illumination 5460-700-033

GUDID 00850025993234

Standard Comfort Pad (Quasar) w/ Stryker Branding - 10 Pack

Enova Illumination, Inc.

Head-worn lamp
Primary Device ID00850025993234
NIH Device Record Keycf4e3d86-51dd-45f3-b86f-a1712e68a929
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnova Illumination
Version Model Number5460-700-033
Catalog Number5460-700-033
Company DUNS080805136
Company NameEnova Illumination, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com
Phone13135597444
Emailjward@goenova.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850025993234 [Primary]

FDA Product Code

HPPHeadlamp, Operating, Battery-Operated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-21
Device Publish Date2021-01-13

On-Brand Devices [Enova Illumination]

00850025993241Deluxe comfort pad set (Quantum) w/ Stryker Branding - 10 Pack
00850025993234Standard Comfort Pad (Quasar) w/ Stryker Branding - 10 Pack
00850025993227Deluxe comfort pad set (Quantum) w/ Stryker Branding - 3 Pack
00850025993210Standard Comfort Pad (Quasar) w/ Stryker Branding - 3 Pack
00850025993203Stryker Black DRH w/ Occip Quantum Warm Surgical Headlight
00850025993197Stryker Black SRH Quasar Cool LED Surgical Headlight
00850025993180Stryker Black SRH Quasar Warm Surgical Headlight
00850025993173Stryker Black DRH w/ Occip Quantum Cool Surgical Headlight
00850025993166Gray Twist Cable (Quantum) w/ Stryker Branding
00850025993159Stryker Power Pack Base Station w/ C13 Power Cord
00850025993142Black Extension Cable (Quasar) w/ Stryker Branding
00850025993135NA C-13 Power Cord for Power Pack Base Station - Stryker
00850025993128Battery Belt - Stryker
00850025993111Occipital Comfort Pad (Quantum) w/ Stryker Bag
00850025993104Standard comfort pad set (Quasar) w/ Stryker Bag
00850025993098Stryker Composite Carrying Case
00850025993081Deluxe comfort pad set (Quantum) w/ Stryker Bag
00850025993074Occipital Mesh Replacement - w/ Stryker Bag
00850025993067Black DRH w/ Occip Support and attached bracket w/ Stryker Bag
00850025993050Black SRH and attached bracket w/ Stryker Bag
00850025993005Stryker PP4 Power Pack
00850025993272Clip-on LED Light System with Battery Accessories
00850025993265Surgical Loupes
00850025993258LED Surgical Headlight Mounted on Headband with Battery Accessories
00850025993746European Power Cord – C13
00850025993739North American Power Cord – C13
00850025993722Battery Belt
00850025993715Black Snap Cable
00850025993708Black Extension Cable
00850025993692Grey Twist Battery Cable
00850025993685Black Twist Battery Cable
00850025993678Composite Carrying Case
00850025993661Extra Large Soft-Sided Case
00850025993654Soft-Sided Case
00850025993647Power Pack Base Station
00850025993630FS3 Battery Charger
00850025993623PP Single Battery Charger
00850025993616PP4 – Power Pack
00850025993609PP2 – Power Pack
00850025993593PP1.5 Power Pack
00850025993586FS3 – FreeStyle
00850025993579Quantum Warm/PLT-175A LED Surgical Light
00850025993562PLT-165A LED Surgical Light
00850025993555Quasar Warm/PLT-115A LED Surgical Light
00850025993548PLT-100A LED Surgical Light
00850025993531Qubit Warm/PLT-80F LED Surgical Light
00850025993524PLT-60F LED Surgical Light
00850025993517PLT-ENT LED Surgical Light
00850025993500Quantum Cool/XLT-250A LED Surgical Light
00850025993494XLT-225A LED Surgical Light

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