AccessGUDID - DEVICE: CUSA® Excel (10381780248248)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® Excel
Version or Model: C4604ELTUS
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780248248
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: The extended life laparoscopic tip is intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical Aspirator System, CUSA® Handpiece and accessories. The CUSA Excel System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: • Neurosurgery • Gastrointestinal and affiliated organ surgery • Urological surgery • Plastic and reconstructive surgery • General surgery • Orthopedic surgery • Gynecological surgery • Thoracic surgery • Laparoscopic surgery • Thoracoscopic surgery

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:	No
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?
44754	Soft-tissue ultrasonic surgical system handpiece tip, reusable	A 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 is a device that is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LBK	Device, neurosurgical fragmentation and aspiration
LFL	Instrument, ultrasonic surgical

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Temperature -34°C to 65°C ; Humidity 25% to 85% RH non condensing ;Keep Dry

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Length 30.14 cm; Diameter 1.98mm

Device Record Status

Public Device Record Key: beceb743-8732-43cf-98e9-46a64b98b23b
Public Version Date: April 14, 2023
Public Version Number: 6
DI Record Publish Date: December 29, 2016