Organization name

Integra LifeSciences Production Corporation

SRN

US-MF-000009189

Manufacturer status

Active

14 warnings recorded — scroll inside the panel to see all entries.

• Avoid activating ultrasonics when using the tip cleaner to clean a tip during a surgical procedure.

  OTHER

• Avoid contacting bone with the CUSA Excel tips (excluding SaberTip©„¢).

  OTHER

• Avoid excessive lateral loading of CUSA Excel sterile tips.

  OTHER

• CUSA Excel tips utilize silicone flues. Compressing the flue against the side of the vibrating surface along the length of the tip can cause excessive heating and potential hazard to adjacent tissue, such as burns.

  OTHER

• Excessive loading of CUSA Excel tips at the surgical site can induce heating due to vibration and acoustic power transmissions. Thermal management of the surgical site with the aid of the appropriate irrigation and aspiration settings is essential.

  OTHER

• For single patient use only. Do not reprocess or re-use. Device(s) is (are) intended to be used for one procedure only. If reprocessed or re-used this may result in the infection of patient (or patient specimen) through cross-contamination, as well as would incur the risk of modifying the properties and performance of the device, and of increasing the likelihood of complications and/or undesirable effects. Once used, devices must be disposed of in accordance with hospital policies.

  OTHER

• For single patient use only. Do not reprocess or re-use.

  OTHER

• No modification of this equipment is allowed.

  OTHER

• Only use Integra handpiece and handpiece accessories with the CUSA Excel System. Non-Integra handpiece and accessories are not supported.

  OTHER

• The handpiece and handpiece accessories must be sterile before surgical use.

  OTHER

• The handpiece and handpiece accessories must be sterile before use. Before use, sterilize the sterilizable torque base in the sterilizer tray with the handpiece.

  OTHER

• Touching of the tip of the handpiece by the operator, while powered, can result in personal injury.

  OTHER

• Turning the torque wrench further clockwise will damage the handpiece. You must use the torque base when assembling and dissembling the tip from the handpiece. Failure to use a torque base could result in a twisted transducer within the handpiece assembly, potentially damaging the transducer, and leading to handpiece failure. Symptoms of an over-torqued handpiece include: - Difficulty inserting the aspiration tubing into the nosecone - Inadequate aspiration - Lower than expected handpiece power output

  OTHER

• When the handpiece is powered on, contact of the tip with a hard surface (e.g. a metal instrument, tray, staples, clips, instruments, etc.) may damage the tip of the handpiece and require replacement before use.

  OTHER

Primary placement in Belgium; available across 20 countries total.

Trade name

CUSA® Excel

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

10381780025979

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

B-10381780025979

Reference / catalog number

C4607S

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class III

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

EXcel 36kHz Straight Extended PrecisionTip™ and Flue

Additional information URL

https://labeling.integralife.com/

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• K020299DEVICES FOR SURGERY WITH ULTRASONIC GENERATOR, SINGLE-USE - OTHER

• Class III medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.