Ceiling Mount LED Light

Primary DI
00850043433491
Brand
Ceiling Mount LED Light
Company
Engle Dental Systems, LLC
Model
P024735
Catalog number
P024735
Device description
MAIA Ceiling Mount LED light
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAZLight, Operating, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAZLight, Operating, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850043433491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850043433491008500434334918500434334910850043433491

GMDN Terms#

Term, Definition table
TermDefinition
LED dental light, line-poweredA mains electricity (AC-powered) device designed for use in dentistry to project an intense focused beam of light directly into or around the oral cavity of a patient via a light-emitting diode (LED) situated as the light head at the distal end of the device's light wand, to illuminate the site of a dental examination or procedure. The light head is connected to a light-intensity control unit and a transformer that supplies mains, stepped-down, low-voltage electricity (e.g., 12 volt), via a flexible cable; for oral cavity illumination, the light wand may be attached to a suction cannula, a dental chair headrest, or to a retractor hooked on the patient's lower jaw. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)547-1906support@engledental.com

Regulatory Flags#

DUNS number
039794292
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850043433521E300 Delivery SystemP070916P0709162026-02-09
00850043433514E300 Dr./Asst Rear DeliveryP070905P0709052025-08-26
00850043433507Cabinet Side Mt Rear Delivery Asst OnlyP071470P0714702024-11-06
00850043433484E2 360 Delivery SystemP070941P0709412023-12-14
00850043433002Cabinet Top Mount Rear DeliveryP071438P0714382022-12-07
00850043433163E300 Dental ChairP096540P0965402022-12-07
00850043433187360 LED LightP024730P0247302022-12-07

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