FDA.reportPublic FDA data

Premio 40 - Light

Primary DI
03760262493381
Brand
Premio 40 - Light
Company
SEDATELEC
Model
PREMIO 40
Catalog number
112953
Device description
The PREMIO 40 Light is an active device intended to illuminate an area or a point of the patient's body in the visible spectrum by a light emission which can be filtered and / or frequency.
Published
2021-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760262493381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760262493381037602624933813760262493381

GMDN Terms#

Term, Definition table
TermDefinition
Fixed examination/treatment room 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
266031462
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
03760262493107PREMIO 10 MOXAPREMIO 101112372016-09-22
03760262490625BAT02 Glass rodsBAT021036072024-04-25
03760262490670EASYO 1 - Multi Pressure FeelerEASYO 11123532024-04-25
03760262492902PAL130 Pressure feeler 130gPAL1301036092024-04-25
03760262492919PAL250 Pressure feeler 250gPAL2501033042024-04-25
03760262492926PAL400 Pressure feeler 400gPAL4001036102024-04-25
03760262492933PAL650 Pressure feeler 650gPAL6501036112024-04-25
03760262490557ASPASPTEST1106402023-01-12
03760262493404ASPASPMA3201132012023-01-12
03760262493411ASPASPMG3201132022023-01-12
03760262493428ASPASPMT3201132032023-01-12
03760262493435ASPASPMA1201132042023-01-12
03760262493442ASPASPMG1201132052023-01-12
03760262493459ASPASPMT1201132062023-01-12
03760262493466ASPASPMTEST1132072023-01-12
03760262493473ASPASPA641132082023-01-12
03760262493480ASPASPG641132092023-01-12
03760262493497ASPASPT641132102023-01-12
03760262490427ASPASPA81106362016-09-22
03760262490465ASPASPG81106372016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
B366LED0204R00PORTALEDEclerisKYT2026-02-11
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
B366LED0203PORTALEDEclerisKYT2025-11-21
10860008900361ClearSpecClearspec LLCKYT2025-10-29
20860008900368ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
00714646001375Rechargeable Light SourceBionix, LLCKYT2025-02-25
07290016672756TytoProTYTO CARE LTDKYT2024-05-26
07290016672763TytoHomeTYTO CARE LTDKYT2024-05-26
04053755201617DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
04053755201655DELTA 30 PROHeine Optotechnik GmbH & Co. KGKYT2024-02-06
00811331011654TruBrite Adhesive Retractor LightTz Medical, Inc.KYT2023-10-20
00816835024254IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024261IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024278IsoLED Flex I LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024285IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00816835024292IsoLED Flex III LED Exam LightMedical Illumination International Inc.KYT2023-10-02
00810132041792HCSConcordance Healthcare Solutions LLCKYT2023-07-28
00810114912010SurgiTelSurgitelKYT2023-01-12
00810114912027SurgiTelSurgitelKYT2023-01-12
00810114912034SurgiTelSurgitelKYT2023-01-12
00810114912041SurgiTelSurgitelKYT2023-01-12
00810114912058SurgiTelSurgitelKYT2023-01-12
00810114912065SurgiTelSurgitelKYT2023-01-12
00634782099480Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099497Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099503Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099510Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11
00634782099527Pro's Combo™AMERICAN DIAGNOSTIC CORPKYT2023-01-11