FDA.reportPublic FDA data

Midmark

Primary DI
00841709107207
Brand
Midmark
Company
MIDMARK CORPORATION
Model
153818-004
Catalog number
153818-004
Device description
The Midmark Elevance and Procenter Console Mounted Dental Halogen Light 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
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00841709107207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709107207008417091072078417091072070841709107207

GMDN Terms#

Term, Definition table
TermDefinition
Reflective dental lightA mains electricity (AC-powered) device designed for use in dentistry to project an intense and focused beam of light typically into or around the oral cavity of a patient to illuminate the site of a dental examination or procedure. It is constructed as a curved reflector with a dedicated central light bulb that produces and focuses the light, an outer housing with handles for dental staff to hold when manoeuvring the light head, and a jointed support arm. This device may be incorporated into a dental delivery system or be fixed separately to the ceiling or other support.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-5 Degrees Celsius38 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-5 Degrees Celsius38 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)643-6275support@midmark.com

Regulatory Flags#

DUNS number
005036025
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709124808Ritter228-001228-0012026-08-27
00841709124815Ritter228-002228-0022026-08-27
00841709124822Ritter228-003228-0032026-08-27
00841709124846Ritter229-002229-0022026-08-27
00841709124853Ritter229-003229-0032026-08-27
00841709109669Midmark626-005626-0052019-10-04
00841709109676Midmark626-006626-0062019-10-04
00841709105920Midmark626-001626-0012018-02-27
00841709105937Midmark626-002626-0022018-02-27
00841709105944Midmark626-003626-0032018-02-27
00841709105951Midmark626-004626-0042018-02-27
00841709105968Midmark627-011627-0112018-02-27
00841709105975Ritter225-002225-0022018-02-27
00841709105982Ritter225-003225-0032018-02-27
00841709105999Ritter224-001224-0012018-02-27
00841709106002Ritter224-002224-0022018-02-27
00841709106019Ritter224-003224-0032018-02-27
00841709106026Ritter224-011224-0112018-02-27
00841709105715MidmarkQC3R-01QC3R-012017-06-23
00841709105722MidmarkQC6R-01QC6R-012017-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719965090020LED Operating LightCHUAN FU MEDICAL INSTRUMENT CO., LTD.EAZ2026-10-22
08033837933021CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837933045CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938583CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938606CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938644CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938682CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938699CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938705CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938712CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938729CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938736CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
08033837938743CEFLACEFLA SOCIETA' COOPERATIVAEAZ2026-10-13
00841709125638MidmarkMIDMARK CORPORATIONEAZ2026-07-08
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