N/A CTD-HL-001

GUDID 08800012341007

Head-worn lamp

Primary Device ID	08800012341007
NIH Device Record Key	9e2fd63c-9440-4cf6-85f0-01fdf3c979c7
Commercial Distribution Status	In Commercial Distribution
Brand Name	N/A
Version Model Number	BT-410A
Catalog Number	CTD-HL-001
Company DUNS	689908411
Company Name	Bistos Co., Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	08800012341007 [Primary]
GS1	18800123410071 [Package] Package: Carton Box [5 Units] In Commercial Distribution

KYT	Light, Examination, Medical, Battery Powered

Steralize Prior To Use	false
Device Is Sterile	false

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