FDA.reportPublic FDA data

n/a

Primary DI
00858308006190
Brand
n/a
Company
Ergonomic Products, Inc.
Model
L1A1
Catalog number
L1A1
Device description
Aurora LS
Published
2022-09-07
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
00858308006190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858308006190008583080061908583080061900858308006190

GMDN Terms#

Term, Definition table
TermDefinition
Operating room lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-488-4793equip@ergonmic-products.com

Regulatory Flags#

DUNS number
051194887
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
true
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
00858308006534Harmony Open Bay WorkstationD1H1D1H12025-04-15
00858308006527N/AD1F2D1F22023-06-06
00858308006510N/AD1F1D1F12023-01-03
00858308006435n/aD1C1D1C12022-09-07
00858308006336n/aD1D4D1D42022-08-19
00858308006343n/aD1D1D1D12022-08-19
00858308006350n/aD1D2D1D22022-08-19
00858308006367n/aD1E2D1E22022-08-19
00858308006374n/aD1E4D1E42022-09-07
00858308006381n/aD1E1D1E12022-08-19
00858308006398n/aD1B4D1B42022-08-19
00858308006404n/aD1B2D1B22022-09-07
00858308006411n/aD1E3D1E32022-08-19
00858308006428n/aL2A1L2A12022-09-07
00858308006442n/aS1A1S1A42022-09-07
00858308006459n/aS1A2S1A22022-09-07
00858308006466n/aS1A3S1A32022-09-07
00858308006473n/aS1A4S1A42022-09-07
00858308006480n/aD3A1D3A12022-09-07
00858308006497n/aD2A1D2A12022-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456221372JMUJMU DENTAL, INCEAZ2026-07-06
00840456221389JMUJMU DENTAL, INCEAZ2026-07-06
00840456221396JMUJMU DENTAL, INCEAZ2026-07-06
00840456221402JMUJMU DENTAL, INCEAZ2026-07-06
00840456221419JMUJMU DENTAL, INCEAZ2026-07-06
00840456221426JMUJMU DENTAL, INCEAZ2026-07-06
00841709121920MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122088MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122217MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709121906MidmarkMIDMARK CORPORATIONEAZ2026-03-18
00841709121913MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121937MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121944MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121951MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121968MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121975MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121982MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709121999MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122002MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122019MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122026MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122033MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122040MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122057MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122064MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122071MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122095MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122101MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122118MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122125MidmarkMIDMARK CORPORATIONEAZ2026-03-10