DEVICE: N/A (08800012341007)

Device Identifier (DI) Information

N/A
BT-410A
In Commercial Distribution
CTD-HL-001
Bistos Co., Ltd.
08800012341007
GS1

1
689908411 *Terms of Use
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.
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Device Characteristics

MR Unsafe
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KYT Light, Examination, Medical, Battery Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

9e2fd63c-9440-4cf6-85f0-01fdf3c979c7
June 15, 2021
1
June 07, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
18800123410071 5 08800012341007 In Commercial Distribution Carton Box
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
949-614-8745
info@bistosamerica.com
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