AccessGUDID - DEVICE: CUSA® Clarity (10381780126294)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® Clarity
Version or Model: C7300EA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C7300EA
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780126294
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: CUSA® Clarity Quick Connect Cartridge and Tubing Set

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:	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?
47625	Surgical irrigation/aspiration tubing set	A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. 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 [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Keep Dry
Storage Environment Temperature: between -18 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity
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: dd3341b4-0e52-411e-bd4b-0129be2e37c1
Public Version Date: April 14, 2023
Public Version Number: 9
DI Record Publish Date: November 23, 2016