FDA.reportPublic FDA data

SurgiTel

Primary DI
00810114912065
Brand
SurgiTel
Company
Surgitel
Model
Surgical Headband 2.0 LED
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
00810114912065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810114912065008101149120658101149120650810114912065

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
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
B366LED0204R00PORTALEDEclerisKYT2026-02-11
B366LED0204PORTALEDEclerisKYT2026-01-23
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
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