N/A CTD-HL-001

GUDID 18800012341011

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.

Bistos Co., Ltd.

Head-worn lamp
Primary Device ID18800012341011
NIH Device Record Keyc320ed9e-df53-44fa-a082-b63ac8b8161a
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberBT-410F
Catalog NumberCTD-HL-001
Company DUNS689908411
Company NameBistos Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com
Phone949-614-8745
Emailinfo@bistosamerica.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108800012341014 [Primary]
GS118800012341011 [Package]
Contains: 08800012341014
Package: Carton Box [5 Units]
In Commercial Distribution

FDA Product Code

KYTLight, Examination, Medical, Battery Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-15
Device Publish Date2021-06-07

On-Brand Devices [N/A]

00887529000373This Head-worn light is used for medical examination by fixing it on the head and illuminating w
00887529000366This Head-worn light is used for medical examination by fixing it on the head and illuminating w
10887529000189Cart for BT-400 Neonatal phototherapy
10887529000134BT-500 Infant incubator consists of Hood, Control Box, LCD external monitor and main body with s
10887529000110BT-400 Neonatal phototherapy is designed to emit the blue light wave length range 450-470nm spec
10887529000103BT-300 is the fetal monitor that measures the fetal heart rate(FHR) which may be evaluated to pr
30887529000091Bistos’ BT-220C is a pocket size Fetal Doppler that measures the fetal heart rate and out put
30887529000084Bistos’ BT-220L is a pocket size Fetal Doppler that measures the fetal heart rate and out put
10887529000066BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Usi
10887529000059BT-350 is the fetal monitor that measures the fetal heart rate(FHR) and uterine contraction. Usi
30887529000046Bistos’ BT-200T is a pocket size Fetal Doppler that measures the fetal heart rate and out put
18800012341011This Head-worn light is used for medical examination by fixing it on the head and illuminating w
08800012341007This Head-worn light is used for medical examination by fixing it on the head and illuminating w

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.