AccessGUDID - DEVICE: CUSA® Clarity (10381780536376)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® Clarity
Version or Model: C7523XEA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C7523XEA
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780536376
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: CUSA Clarity 23kHz Expanded CEM Nosecone (Single Pack)

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":	Yes
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?
47547	Ultrasonic surgical system adaptor, single-use	A small, sterile, 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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFL	Instrument, ultrasonic surgical
LBK	Neurosurgical ultrasonic instruments

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230427	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 Temperature: between -18 and 60 Degrees Celsius
Handling Environment Temperature: between 10 and 35 Degrees Celsius
Special Storage Condition, Specify: Keep Dry, Do not use if package is damaged
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 26db582c-ef3f-45fd-99d3-2705e3063c1d
Public Version Date: July 24, 2023
Public Version Number: 1
DI Record Publish Date: July 14, 2023