AccessGUDID - DEVICE: CUSA® Clarity (10381780533887)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® Clarity
Version or Model: C7404LSEA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C7404LSEA
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780533887
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: 23kHz Extended Length Laparoscopic Tip

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):	Yes
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?
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
LBK	Device, neurosurgical fragmentation and aspiration

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221763	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Special Storage Condition, Specify: Keep Dry; Do not use if package is damaged
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -18 and 60 Degrees Celsius
Handling Environment Temperature: between 10 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 500e1108-5c22-4e3f-917e-8ec8e3ffdfcd
Public Version Date: September 14, 2022
Public Version Number: 1
DI Record Publish Date: September 06, 2022