AccessGUDID - DEVICE: CUSA® Clarity (10381780126423)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® Clarity
Version or Model: C7414EUT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C7414EUT
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780126423
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: CUSA® Clarity Extended Use Standard Tip (EUT) Pack 36kHz: Tip, Flue Assembly, Nosecone, Tip Cleaner

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
44754	Soft-tissue ultrasonic surgical system handpiece tip, reusable	A 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 is a device that is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFL	Instrument, ultrasonic surgical
LBK	Device, neurosurgical fragmentation and aspiration

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
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -18 and 60 Degrees Celsius
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf67e07f-b92b-4447-a246-ded184a7483c
Public Version Date: April 14, 2023
Public Version Number: 5
DI Record Publish Date: February 08, 2019