FDA.reportPublic FDA data

Tri Star

Primary DI
00853538008266
Brand
Tri Star
Company
Sunnex
Model
TS2015W-AU
Catalog number
TS2015W-AU
Published
2018-02-26
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
00853538008266PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853538008266008535380082668535380082660853538008266

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
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)445-7869bill.long@sunnex.com

Regulatory Flags#

DUNS number
073797367
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853538008631Leo MinorLMI-700-AULMI-700-AU2021-12-09
00853538008648Celestial StarCS2050C-39CS2050C-392021-12-09
00853538008617Celestial StarCSLED-DLA29CSLED-DLA292019-01-24
00853538008624Leo MinorLMI-700-EULMI-700-EU2019-03-28
00853538008006Celestial StarCS2050MCS2050M2018-02-26
00853538008013Celestial StarCS2050WCS2050W2018-02-26
00853538008020Celestial StarCS2050CCS2050C2018-02-26
00853538008037Celestial StarCS2050DCS2050D2018-02-26
00853538008044Celestial StarCS2050C-MRICS2050C-MRI2018-02-26
00853538008051Celestial StarCS2050D-29LACS2050D-29LA2018-02-26
00853538008068Celestial StarCS2050D-MRICS2050D-MRI2018-02-26
00853538008075Celestial StarCS2050M-ECS2050M-E2018-02-26
00853538008082Celestial StarCS2050M-MRICS2050M-MRI2018-02-26
00853538008099Celestial StarCS2050M-MRI-ECS2050M-MRI-E2018-02-26
00853538008105Celestial StarCS2050M-MRI-UKCS2050M-MRI-UK2018-02-26
00853538008112Celestial StarCS2050M-UKCS2050M-UK2018-02-26
00853538008129Celestial StarCS2050W-ECS2050W-E2018-02-26
00853538008136Celestial StarCS2050W-UKCS2050W-UK2018-02-26
00853538008143Celestial StarCSLED-MCSLED-M2018-02-26
00853538008150Celestial StarCSLED-WCSLED-W2018-02-26

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