DEVICE: LHP-6/L5M/MCC6 assy. (04582227341365)

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Device Record History
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Device Identifier (DI) Information
LHP-6/L5M/MCC6 assy.
LHP-6/L5M/MCC6
In Commercial Distribution
51099
OSADA ELECTRIC CO.,LTD.
04582227341365
GS1

1
690713813 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
Yes
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?
34699 Dental laboratory drilling system motor
A mains electricity (AC-powered) engine (motor) used in a dental laboratory in conjunction with a flexible drive system (e.g., a Bowden cable) to provide the rotational power for a dental laboratory handpiece. It is typically combined with different speed controllers. This is a reusable device.
Active false
34700 Dental laboratory drilling system handpiece
A hand-held device that includes a chuck for attaching drills, burs, grind wheels, and similar rotating devices used in the dental laboratory. The device is typically remote from the power source (e.g., a dental laboratory drill motor) and is connected to this by a flexible drive system, which may be a Bowden cable. This is a reusable device.
Active false
37708 Remotely-driven surgical/dental system drive cable
A flexible device for transmitting rotational power from a remote surgical or dental drilling system motor/control unit to the drilling handpiece. The drive is designed so that the handpiece can be flexibly manipulated by the operator (the surgeon or dentist). The design is typically based on a rotating metal spun spiral cable within a protective sheath; this is commonly known as a Bowden cable. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EKX HANDPIECE, DIRECT DRIVE, AC-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
d0b1127f-ade6-4973-b4c2-08a848531f6a
March 29, 2018
2
September 29, 2016
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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

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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
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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