CUSA® SaberTip™

Basic Information

• Brand Name: CUSA® SaberTip™
• Primary DI: 10381780026075
• Version / Model: C4616S
• Catalog Number: C4616S
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Labeler DUNS: 989925396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-29
• Public Version: 8
• Public Version Date: 2023-05-16
• Public Version Status: Update
• Public Device Record Key: 16da4fe7-7cae-485d-95c0-5a356df68bcf

Device Description

CUSA® Excel SaberTip™ (IV) 36kHz 1.14mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBK	Device, neurosurgical fragmentation and aspiration	Unknown		U
LFL	Instrument, ultrasonic surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
44755	Soft-tissue ultrasonic surgical system handpiece tip, single-use	A sterile 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 device is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780026079	GS1	BOX	4	In Commercial Distribution
Primary	10381780026075	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.14mm ID x 11.50cm length; 7.86g weight; 36kHz frequency

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Temperature -34°C to 65°C; Relative Humidity 25% to 85%, non-condensing; Keep Dry.