FDA.reportPublic FDA data

MTI

Primary DI
10840118404850
Brand
MTI
Company
Medical Technology Industries, Inc.
Model
1000210
Catalog number
1000210
Device description
Exam Light, CLARUS 4 LED w/Caster Base
Published
2020-02-03
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
KZFDevice, Medical Examination, Ac Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZFDevice, Medical Examination, Ac PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840118404850PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084011840485010840118404850

GMDN Terms#

Term, Definition table
TermDefinition
Fixed examination/treatment lightA fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
801-887-5114customer.service@mti.net

Regulatory Flags#

DUNS number
053947946
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
10840118422267MTI330-01-214330-01-2142020-02-03
10840118422274MTI330-01-217330-01-2172020-02-03
10840118422281MTI330-01-221330-01-2212020-02-03
10840118422298MTI330-01-238330-01-2382020-02-03
10840118422304MTI330-01-241330-01-2412020-02-03
10840118422311MTI330-01-218330-01-2182020-02-03
10840118422328MTI330-01-219330-01-2192020-02-03
10840118422335MTI330-01-239330-01-2392020-02-03
10840118422342MTI330-01-237330-01-2372020-02-03
10840118422359MTI330-01-240330-01-2402020-02-03
10840118422366MTI330-01-216330-01-2162020-02-03
10840118422373MTI330-01-220330-01-2202020-02-03
10840118422380MTI330-01-998330-01-9982020-02-03
10840118422397MTI330-01-215330-01-2152020-02-03
10840118422403MTI330-01-242330-01-2422020-02-03
10840118422410MTI330-01-222330-01-2222020-02-03
10840118422427MTI330-01-228330-01-2282020-02-03
10840118422434MTI330-01-236330-01-2362020-02-03
10840118422441MTI330-01-245330-01-2452020-02-03
10840118422458MTI330-01-244330-01-2442020-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095543954zumaxZumax Medical Co., LTDKZF2026-05-21
00858480006339NOVABurton Medical, LLCKZF2026-04-02
00858480006346 NOVABurton Medical, LLCKZF2026-04-02
00858480006827 OPLEDBurton Medical, LLCKZF2026-04-02
00858480006834 AIM HIBurton Medical, LLCKZF2026-04-02
00858480006841 AIM HIBurton Medical, LLCKZF2026-04-02
00858480006858 AIM LEDBurton Medical, LLCKZF2026-04-02
00724995244286HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244309HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244330HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244347HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244378HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244293HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244354HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244361HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244385HexaLuxSTERIS CORPORATIONKZF2025-05-05
04250365155471ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155488ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155495ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155839ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155860ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365174434ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365174441ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365175530ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365189797ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
00724995225070NASTERIS CORPORATIONKZF2024-11-25
00724995225179NASTERIS CORPORATIONKZF2024-11-25
00724995225186NASTERIS CORPORATIONKZF2024-11-25
00724995225667NASTERIS CORPORATIONKZF2024-11-25
00724995225674NASTERIS CORPORATIONKZF2024-11-25