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
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
00814005024486RADFIL2QUALITY ASPIRATORS, INC.KYT2025-02-27