N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00887529000342
• Version / Model: BT-410A
• Catalog Number: CTD-HL-001
• Company Name: Bistos Co., Ltd.
• Labeler DUNS: 689908411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 2
• Public Version Date: 2019-02-07
• Public Version Status: Update
• Public Device Record Key: 7625992e-9468-4ad1-84d3-abc415288564

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HPP	Headlamp, Operating, Battery-Operated	Ophthalmic	886.4335	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46807	Head-worn lamp	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00887529000366	GS1	Gift Box	1	In Commercial Distribution
Primary	00887529000342	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]