FDA.reportPublic FDA data

N/A

Primary DI
08800012341014
Brand
N/A
Company
Bistos Co., Ltd.
Model
BT-410F
Catalog number
CTD-HL-001
Device description
This Head-worn light is used for medical examination by fixing it on the head and illuminating with condensed light to the injured part. This unit doesn't intend to contact directly to the patient's body and can be used for all medical field except ophthalmology.
Published
2021-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

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
18800012341011PackageGS15In Commercial Distribution
08800012341014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880001234101118800012341011
08800012341014088000123410148800012341014

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.

Contacts#

Phone, Email table
PhoneEmail
949-614-8745info@bistosamerica.com

Regulatory Flags#

DUNS number
689908411
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887529000410Hi bebe superBT-150B2026-05-15
00887529000502N/ABT-10002026-05-15
00887529000519BT-1000 electrodeN/A2026-05-15
08800012315022Hi bebe superBT-150L2021-06-08
08800012315039Hi bebe superBT-150S2021-06-08
00887529000014Hi-dopBT-200VOSD-14200V-0012016-06-14
00887529000021Hi-bebeBT-200SMKT-200-15012016-06-03
00887529000038Hi-bebeBT-200LMKT-200-15012016-06-01
00887529000045N/ABT-200TMKT-200-15012016-06-14
00887529000052N/ABT-350LMKT-350-15092016-06-03
00887529000069N/ABT-350EMKT-350-15092016-06-03
00887529000083N/ABT-220LOSD-14220-0012016-06-03
00887529000090N/ABT-220COSD-14220-0012016-06-03
00887529000106N/ABT-300OSD-15300-0012016-06-14
00887529000199Hi-bebeBT-200C2018-03-16
00887529000465Duo Double Electric Breast PumpAAA00212021-10-28
08800012345012BiliTouchTMMotif Phototherapy Blanket2021-06-09
18800012345019BiliTouchTMMotif Phototherapy Blanket2021-06-09
08800012345005Infant Phototherapy EquipmentBT-4502021-06-08
18800012315029Hi bebe superBT-150L2021-06-08

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
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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