AccessGUDID - DEVICE: CUSA® Selector® (10381780121916)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® Selector®
Version or Model: 1523046
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1523046
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780121916
Issuing Agency: GS1
Commercial Distribution End Date: September 03, 2024
Device Count: 20
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: CUSA® Selector® 24KHz Neuro Short Flue (Pack of 20)

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:	Yes
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?
45184	Ultrasonic surgical system flue	A sterile device used to encompass the distal end of a dedicated ultrasonic surgical system handpiece and tip to provide a pathway for the delivery of irrigation fluid. The device helps to concentrate the fluid at the tip of the handpiece, remove some of the heat generated during surgery, eliminate misting that can impair visibility of the surgical site, and reduce the amount of irrigant needed. 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

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
Special Storage Condition, Specify: Temperature: -20°C (-4°F) to +60°C (+140°F). Relative Humidity, non-condensing: +25% to +85%. Avoid excessive heat and humidity. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 24kHz Ultrasonic Frequency

Device Record Status

Public Device Record Key: c0e6f2c6-5e9c-42f0-93b3-f1805b56a381
Public Version Date: October 28, 2024
Public Version Number: 6
DI Record Publish Date: December 29, 2016