CUSA® NXT

GUDID 30381780039482

The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

INTEGRA LIFESCIENCES (IRELAND) LIMITED

Soft-tissue ultrasonic surgical system handpiece tip, single-use
Primary Device ID30381780039482
NIH Device Record Keyc6036488-72c9-4229-9b93-ab84d01c89fe
Commercial Distribution Discontinuation2024-09-03
Commercial Distribution StatusNot in Commercial Distribution
Brand NameCUSA® NXT
Version Model NumberNXT3220
Company DUNS989925396
Company NameINTEGRA LIFESCIENCES (IRELAND) LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780039488 [Primary]
GS130381780039482 [Package]
Contains: 10381780039488
Package: BOX [5 Units]
Discontinued: 2024-09-03
Not in Commercial Distribution
HIBCCM269NXT322011 [Secondary]

FDA Product Code

LFLInstrument, ultrasonic surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-11-20
Device Publish Date2016-12-29

On-Brand Devices [CUSA® NXT]

30381780040297Tubing Kit - Box Of 10: The Selector tubing connects the handpiece to the IV fluid and connects
30381780040259MRI Tubing Kit Extension:The Selector tubing connects the handpiece to the IV fluid and connects
10381780039525NXT Contamination Guard BOX2: The CUSA NXT Contamination Guard is fitted to the service module t
M273NXT100011The CUSA NXT footswitch is a device with two pedals used separately to control power and rate of
M273CUSANXT21The CUSA NXT service module houses the aspiration and irrigation subsystems controlled by the CU
M273CUSANXT11The CUSA NXT service module houses the aspiration and irrigation subsystems controlled by the CU
M273CUSANXT1The CUSA NXT console provides a touch screen interface for controlling the delivery of aspiratio
10381780039495Integra® CUSA NXT™
10381780039471Integra® CUSA NXT™
M269NXT3218EA1Integra® CUSA NXT™
M273NXT800031Integra® CUSA NXT™
M273NXT800021Integra® CUSA NXT™
M273NXT800011Integra® CUSA NXT™
M610152324315The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Select
30381780039482The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that
30381780039468The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that
30381780039444The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that

Trademark Results [CUSA]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CUSA
CUSA
97880179 not registered Live/Pending
Conference USA, Inc.
2023-04-10
CUSA
CUSA
86488383 5055280 Live/Registered
Credentialing USA, Inc.
2014-12-22
CUSA
CUSA
86386901 5105500 Live/Registered
Credentialing USA, Inc.
2014-09-05
CUSA
CUSA
85226675 4012505 Live/Registered
Fiserv, Inc.
2011-01-26
CUSA
CUSA
78914847 not registered Dead/Abandoned
Corrections U.S.A.
2006-06-22
CUSA
CUSA
78262975 2946715 Dead/Cancelled
CUSA, LLC
2003-06-16
CUSA
CUSA
76311200 2639112 Dead/Cancelled
NATIONAL SAFETY COUNCIL,
2001-09-07
CUSA
CUSA
75703117 2437564 Dead/Cancelled
NATIONAL SAFETY COUNCIL
1999-05-11
CUSA
CUSA
75574524 2396920 Dead/Cancelled
Capital USA LLC
1998-10-21
CUSA
CUSA
73746855 1648672 Dead/Cancelled
CUSA, INC.
1988-08-18
CUSA
CUSA
73746854 1659473 Dead/Cancelled
CUSA, INC.
1988-08-18
CUSA
CUSA
73584520 1412194 Live/Registered
COOPER LASERSONICS, INC.
1986-02-24

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.