FDA.reportPublic FDA data

Fiji Headband

Primary DI
00851610007299
Brand
Fiji Headband
Company
LONG ISLAND TECH
Model
P007809
Device description
Surgical Headlight Accessory
Published
2021-06-07
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
00851610007299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851610007299008516100072998516100072990851610007299

GMDN Terms#

Term, Definition table
TermDefinition
Head-worn lampAn electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030256600
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851610007251BayPort Storage SolutionP0036002020-11-02
00851610007091AtoN Keywest Headlight without Fiber Optic CableP0032672016-09-02
00851610007107HatterasP0027002016-09-02
00851610007114AtoN Optic OnlyP0032482016-09-02
00851610007121AtoN Classic Headlight without Fiber Optic CableP0032652016-09-02
00851610007138AtoN Classic Headlight with Cobra Fiber Optic CableP0032492016-09-02
00851610007145AtoN Classic Headlight with 10' Fiber Optic CableP0032552016-09-02
00851610007152AtoN Keywest Headlight with Cobra Fiber Optic CableP0032502016-09-02
00851610007169AtoN Keywest Headlight with 10' Fiber Optic CableP0032572016-09-02
00851610007176AtoN Keywest Headlight with 7' Fiber Optic CableP0032622016-09-02
00851610007183AtoN Classic Headlight with 7' Fiber Optic CableP0032602016-09-09
00851610007220Pharos HD HeadcamP0034052021-06-07
00851610007336Pharos HD CCUP0035052021-06-07
00851610007190Dover Headlight OpticP0025052020-12-21
00851610007206Bristol Headlight OpticP0026052020-12-21
00851610007213Daymark Headlight OpticP0031002020-12-21
00851610007268Dover HolsterP0025502020-12-21
00851610007275Bristol HolsterP0025502020-12-21
00851610007282Daymark HolsterP0031502020-12-21
00851610007244BayPort 6-Bay ChargerP0037002020-11-02

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