DEVICE: Cable MX LED (J00716006060011)
Device Identifier (DI) Information
Cable MX LED
1600606-001
In Commercial Distribution
1600606-001
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
1600606-001
In Commercial Distribution
1600606-001
BIEN-AIR PORTUGAL, UNIPESSOAL, LDA
Accessory connects micro-motors to the console or other boards, thus allowing the control and functioning of the whole device.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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66247 | Dental power tool handpiece motorless component |
A component of a dental power tool handpiece designed to connect between a dental power tool motor and an endpiece to transfer mechanical energy from the motor to the endpiece during a dental surgical procedure. It may be in the form of a torque multiplier, adapter, or motorless handpiece. Neither the motor nor the endpiece is included. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EBW | Controller, foot, handpiece and cord |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
75486840-10cf-4ed2-b087-8a7543887f7d
July 17, 2023
4
June 17, 2021
July 17, 2023
4
June 17, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1 949-477-6050
ba-usa@bienair.com
ba-usa@bienair.com