DEVICE: HARMONIC WAVE (10705036003366)
Device Identifier (DI) Information
HARMONIC WAVE
WAVE18S
In Commercial Distribution
WAVE18S
ETHICON ENDO-SURGERY, LLC
WAVE18S
In Commercial Distribution
WAVE18S
ETHICON ENDO-SURGERY, LLC
Harmonic Wave Coagulating Shears with Scissor Handle and Hand Control. 18cm Long, 18mm Active Blade, 8.5mm Shaft Diameter, Torque Wrench Included
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
44755 | Soft-tissue ultrasonic surgical system handpiece tip, single-use |
A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. The device comes in a variety of forms (e.g., blade, cylinder, pincers) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). This device is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LFL | Instrument, ultrasonic surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -22 and 60 Degrees Celsius |
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
890d8dfc-438c-4591-a439-f18fa252a8ca
October 16, 2019
3
July 15, 2016
October 16, 2019
3
July 15, 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 |
---|---|---|---|---|---|
30705036003360 | 24 | 10705036003366 | In Commercial Distribution | CASE | |
20705036003363 | 6 | 10705036003366 | In Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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(877)384-4266
customersupport@eesus.jnj.com
customersupport@eesus.jnj.com