DEVICE: MECTRON (E322029000800010)

Device Identifier (DI) Information

MECTRON
PS MEDICAL TORQUE WRENCH
In Commercial Distribution
02900080-001
MECTRON SPA
E322029000800010
HIBCC

1
436664734 *Terms of Use
PS MEDICAL TORQUE WRENCH is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
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.
CLOSE

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153743 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

b495a46c-893f-4d0a-a2ec-a648ed4d7641
July 06, 2018
3
August 30, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1 6144594922
info@piezosurgery.us
CLOSE