DEVICE: ITS Model-L6K (08800033200048)

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Device Record History
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Device Identifier (DI) Information
ITS Model-L6K
ITSLC1811, ITSLC1821
In Commercial Distribution

InTheSmart Co., Ltd.
08800033200048
GS1

1
694495825 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
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?
32259 Endoscope cine camera
An electro-optical device that is designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to obtain moving-picture documentation of endoscopic findings and procedures. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It records a sequence of photographs and usually projects them sequentially to obtain a motion picture. The device may also include audio recording capabilities.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FWL Camera, Cine, Endoscopic, Without Audio
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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
f6a8eddd-511e-47a3-9f4d-77065455a03b
November 21, 2022
1
November 11, 2022
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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
No Package DIs found
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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

[?]
Yes
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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