DEVICE: MECTRON (E322029000740010)
Device Identifier (DI) Information
MECTRON
K6
In Commercial Distribution
02900074-001
MECTRON SPA
K6
In Commercial Distribution
02900074-001
MECTRON SPA
K6 is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
47675 | Ultrasonic surgical system torque wrench, reusable |
A hand-held instrument designed to manually attach or detach a handpiece tip (blade) from the handpiece of an ultrasonic surgical system. It is typically formed with a socket that is placed over the handpiece tip and rotated by the operator to tighten or loosen, with appropriate torque, the tip to or from the handpiece. The device is made of durable materials and typically includes a mechanism to prevent under- or over-tightening. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELC | Scaler, Ultrasonic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K140965 | 000 |
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
1d8e306f-d14b-4bed-8876-086b56fa576f
July 06, 2018
3
August 30, 2016
July 06, 2018
3
August 30, 2016
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 |
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 6144594922
info@piezosurgery.us
info@piezosurgery.us