AccessGUDID - DEVICE: MECTRON (E322031202430010)

GUDID

Device Identifier (DI) Information

Brand Name: MECTRON
Version or Model: MANIPOLO PIEZOSURGERY MEDICAL+
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 03120243-001
Company Name: MECTRON SPA

Primary DI Number: E322031202430010
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436664734 *Terms of Use

Device Description: Ultrasonic Medical Handpiece

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47014	Dental ultrasonic surgical system handpiece	A hand-held component of a dental ultrasonic surgical system that typically converts high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and cut bone upon contact during dental surgery. The operator regulates the energy with an electric power switch incorporated into a foot-pedal that is attached to the generator. The handpiece typically includes cables and tubing, and may serve as a conduit for irrigation to the site of intervention. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153743	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8281d2bc-96b4-49c4-bbbe-cd6a921e7f45
Public Version Date: March 13, 2023
Public Version Number: 1
DI Record Publish Date: March 03, 2023