DEVICE: MECTRON (E322036000120)

Device Identifier (DI) Information

MECTRON
MT7-3
In Commercial Distribution
03600012
MECTRON SPA
E322036000120
HIBCC

1
436664734 *Terms of Use
MT7-3 is an osteotomy surgical insert to be used in conjunction with Mectron Piezosurgery handpieces.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Orthopaedic ultrasonic surgical system handpiece tip A removable endpiece intended to be attached to a orthopaedic ultrasonic surgical system handpiece and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment, cut, and shape bone upon contact during an orthopaedic surgical procedure (e.g., spinal surgery); some types may in addition be intended for dental applications. The device is available in a variety of forms (e.g., flat serrated blade, pointed) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). This is a reusable device intended to be sterilized prior to use.
Dental ultrasonic surgical system handpiece tip A removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). It is used for implant site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty, and osteotomy. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
DZI Drill, Bone, Powered
JDX Instrument, Surgical, Sonic And Accessory/Attachment
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FDA Premarket Submission

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

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

8b4ec084-a478-45c4-be46-a32f1340628d
March 29, 2018
2
August 30, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1 6144594922
info@piezosurgery.us
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