FDA.reportPublic FDA data

SurgiTel

Primary DI
00810114912034
Brand
SurgiTel
Company
Surgitel
Model
Wireless LED Headlight
Device description
Suplimentary light source for surgical and dental procedures.
Published
2023-01-12
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
00810114912034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810114912034008101149120348101149120340810114912034

GMDN Terms#

Term, Definition table
TermDefinition
Operating room lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Regulatory Flags#

DUNS number
078566956
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810114911006SurgiTelTTL Loupe2023-07-25
00810114911013SurgiTelFLM Loupe2023-07-25
00810114911020SurgiTelHeadband Loupe2023-07-25
00810114911037SurgiTelWired Light2023-07-25
00810114911044SurgiTelWireless Light2023-07-25
00810114911051SurgiTelSurgiCam2023-07-25
00810114911068SurgiTelTTL Loupe, Wired Light2023-07-25
00810114911075SurgiTelTTL Loupe, Wireless Light2023-07-25
00810114911082SurgiTelFLM Loupe, Wired Light2023-07-25
00810114911099SurgiTelFLM Loupe, Wireless Light2023-07-25
00810114911105SurgiTelHeadband Loupe, Wired Light2023-07-25
00810114911112SurgiTelHeadband Loupe, Wireless Light2023-07-25
00810114911129SurgiTelSurgiCam, Wired Light2023-07-25
00810114911136SurgiTelSurgiCam, Wireless Light2023-07-25
00810114910320SurgiTelEVC250F FLM2023-04-26
00810114910337SurgiTelEVC250M FLM2023-04-26
00810114910344SurgiTelEVC250N FLM2023-04-26
00810114910351SurgiTelEVC250XF FLM2023-04-26
00810114910368SurgiTelEVC300F FLM2023-04-26
00810114910375SurgiTelEVC300M FLM2023-04-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500176518382DermLite SkeenDermLite LLCKYT2026-09-28
00814005025650Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025667Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00814005025674Q-OpticsQUALITY ASPIRATORS, INC.KYT2026-07-02
00714646001559Rechargeable Light SourceBionix, LLCKYT2025-11-22
B366LED0203PORTALEDEclerisKYT2025-11-21
10860008900361ClearSpecClearspec LLCKYT2025-10-29
20860008900368ClearSpecClearspec LLCKYT2025-10-29
00860008900364ClearSpecClearspec LLCKYT2025-10-29
00814005023526RADBL25QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023533RADBLC1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023540RADFILM5QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023571RADHU2QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023595RADHUM4QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005023618RADINST1QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024172RADC25QUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024189RADFILM6QUALITY ASPIRATORS, INC.KYT2025-02-27
008140050242572 Pin Detachable CableQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024288M-CZQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024295M-ORTTL AssemblyQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024301M-COQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024370M-KEQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024387M-HBQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024394M-ORQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024400M-QFQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024431M-SUQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024448M-SUTTLQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024455M-SVQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024462M-TTLQUALITY ASPIRATORS, INC.KYT2025-02-27
00814005024479RADFIL1QUALITY ASPIRATORS, INC.KYT2025-02-27