FDA.reportPublic FDA data

Tri Star

Primary DI
00853538008228
Brand
Tri Star
Company
Sunnex
Model
TS2015M
Catalog number
TS2015M
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
00853538008228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853538008228008535380082288535380082280853538008228

GMDN Terms#

Term, Definition table
TermDefinition
Mobile examination/treatment lightA mobile 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), which reflect the light via reflectors or mirrors depending upon the construction, and will often be mounted on a pantograph counterbalance assembly that is attached to a mobile mount. It is usually used during examination or treatment in locations that do not have the required lighting installed. This device is designed to be easily moved from one location to another.

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