N/A CTD-HL-001

GUDID 00887529000366

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 ID: 00887529000366
• NIH Device Record Key: 7625992e-9468-4ad1-84d3-abc415288564
• 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

Customer Support Contacts

• Phone: 949-614-8745
• Email: info@bistosamerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00887529000342 [Primary]
GS1	00887529000366 [Package]; Contains: 00887529000342; Package: Gift Box [1 Units]; In Commercial Distribution

FDA Product Code

• HPP: Headlamp, Operating, Battery-Operated

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-05-25

On-Brand Devices [N/A]

• 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
• 10887529000189: Cart for BT-400 Neonatal phototherapy
• 10887529000134: BT-500 Infant incubator consists of Hood, Control Box, LCD external monitor and main body with s
• 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