AccessGUDID - DEVICE: CUSA® Excel (10381780026136)

GUDID

Device Identifier (DI) Information

Brand Name: CUSA® Excel
Version or Model: C6636
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C6636
Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED

Primary DI Number: 10381780026136
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 989925396 *Terms of Use

Device Description: CUSA® Excel 36 kHz CEM™ Nosecone

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":	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?
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	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: Temperature -34°C to 65°C; Relative Humidity 25% to 85%, non-condensing; Keep Dry.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 36 kHz frequency

Device Record Status

Public Device Record Key: a7b7246e-67c0-4bcc-95ec-14869125e77b
Public Version Date: April 14, 2023
Public Version Number: 8
DI Record Publish Date: December 29, 2016