AccessGUDID - DEVICE: CUSA® NXT (10381780040255)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® NXT
Version or Model: 1532024
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780040255
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: MRI Tubing Kit Extension:The Selector tubing connects the handpiece to the IV fluid and connects the handpiece to the suction canister on the CUSA® Selector / CUSA NXT console.

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":	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?
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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081459	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
Special Storage Condition, Specify: Storage Temperature -20°C to 60°C; Relative Humidity non condensing 25% to 85%; Avoid excessive heat and humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f8a9d94f-bf95-4952-80b6-8099cfcbc721
Public Version Date: March 08, 2022
Public Version Number: 4
DI Record Publish Date: January 27, 2017