AccessGUDID - DEVICE: Harmonic (20705036002175)

GUDID

Device Identifier (DI) Information

Brand Name: Harmonic
Version or Model: HSA06
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HSA06
Company Name: ETHICON ENDO-SURGERY, LLC

Primary DI Number: 20705036002175
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2016
Device Count: 2
Labeler D-U-N-S® Number*: 044606982 *Terms of Use

Device Description: Harmonic 5mm Adaptor

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?
47546	Ultrasonic surgical system adaptor, reusable	A small connecting device designed to fit between the component devices of an ultrasonic surgical system (i.e., the handpiece tip, handpiece, and generator) to enable them to join each other. It may include controls (e.g., buttons) that allow the operator to activate different power level settings for the system during surgery. This is a reusable 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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Hydrogen Peroxide
Moist Heat or Steam Sterilization
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -35 and 54 Degrees Celsius
Storage Environment Humidity: between 10 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8ce3b82d-a00b-4eed-918e-3da5c915f849
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 15, 2016