FDA.report

Midmark

Primary DI
00841709107498
Brand
Midmark
Company
MIDMARK CORPORATION
Model
153906-018
Catalog number
153906-018
Device description
The Midmark 128 inch Dental LED Track Light without monitor is intended to be used as a component in a dental environment to provide lighting during dental procedures.
Published
2018-05-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EAZLIGHT, OPERATING, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EAZLight, Operating, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841709107498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709107498008417091074988417091074980841709107498

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)643-6275support@midmark.com

Regulatory Flags

DUNS number
005036025
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 DIBrandModelCatalogPublished
00841709121920MidmarkLT-1400-096LT-1400-0962026-03-19
00841709122088MidmarkLT-1600-108LT-1600-1082026-03-19
00841709122217Midmark029-11924-02LT-15002026-03-19
00841709122132Midmark153839-013153839-0132026-03-11
00841709122149Midmark153720-011153720-0112026-03-11
00841709122156Midmark153740-012153740-0122026-03-11
00841709122163Midmark153740-013153740-0132026-03-11
00841709122170Midmark153740-014153740-0142026-03-11
00841709121913MidmarkLT-1300-001LT-1300-0012026-03-10
00841709121937MidmarkLT-1400-102LT-1400-1022026-03-10
00841709121944MidmarkLT-1400-108LT-1400-1082026-03-10
00841709121951MidmarkLT-1400-114LT-1400-1142026-03-10
00841709121968MidmarkLT-1400-120LT-1400-1202026-03-10
00841709121975MidmarkLT-1400-126LT-1400-1262026-03-10
00841709121982MidmarkLT-1400-132LT-1400-1322026-03-10
00841709121999MidmarkLT-1500-096LT-1500-0962026-03-10
00841709122002MidmarkLT-1500-102LT-1500-1022026-03-10
00841709122019MidmarkLT-1500-108LT-1500-1082026-03-10
00841709122026MidmarkLT-1500-114LT-1500-1142026-03-10
00841709122033MidmarkLT-1500-120LT-1500-1202026-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00841709121920MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122088MidmarkMIDMARK CORPORATIONEAZ2026-03-19
00841709122217MidmarkMIDMARK CORPORATIONEAZ2026-03-19
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
00841709122187MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122194MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122200MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122224MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122231MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122248MidmarkMIDMARK CORPORATIONEAZ2026-03-10
00841709122255MidmarkMIDMARK CORPORATIONEAZ2026-03-10