FDA.reportPublic FDA data

ACEMSO15F

Primary DI
08050705890392
Brand
ACEMSO15F
Company
ACEM SPA
Model
ACEMSO15F /SC1
Catalog number
110505
Device description
ACEMSO15F 1-ARM CEILING STANDARD LINE
Published
2020-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
08050705890392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08050705890392080507058903928050705890392

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
435188508
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
08050705890002CIRCLEDCIRCLED /R1100002020-01-31
08050705890415STARLED3 NXSTARLED3 NX /W1106022020-02-04
08050705890019CIRCLEDCIRCLED /D1100012020-01-31
08050705890026CIRCLEDCIRCLED /W1100022020-01-31
08050705890033CIRCLEDCIRCLED /T1100032020-01-31
08050705890040ACEMST1ACEMST1.1 /RR1108002020-01-31
08050705890057ACEMST1ACEMST1.1 /RD1108012020-01-31
08050705890064ACEMST1ACEMST1.1 /RW1108022020-01-31
08050705890071ACEMST1ACEMST1.1 /RT1108032020-01-31
08050705890088ACEMST1ACEMST1.1 /RTB1108042020-01-31
08050705890095ACEMST1ACEMST1.1 /RC1108052020-01-31
08050705890101ACEMST1ACEMST1.3 /RR1110002020-01-31
08050705890118ACEMST1ACEMST1.3 /RD1110012020-01-31
08050705890125ACEMST1ACEMST1.3 /RW1110022020-01-31
08050705890132ACEMST1ACEMST1.3 /RT1110032020-01-31
08050705890149ACEMST1ACEMST1.3 /RTB1110042020-01-31
08050705890156ACEMST1ACEMST1.3 /RC1110052020-01-31
08050705890163ACEMST1ACEMST1.1 /FR1109002020-01-31
08050705890170ACEMST1ACEMST1.1 /FD1109012020-01-31
08050705890187ACEMST1ACEMST1.1 /FW1109022020-01-31

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