Cool-tip

Basic Information

• Brand Name: Cool-tip
• Primary DI: 10884524000930
• Version / Model: ACTC1025
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2023-08-10
• Public Version Status: Update
• Public Device Record Key: 9ea6ad85-ae5f-4ba4-b2dc-9425782a63c7

Device Description

RFA Cluster Electrode Kit

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
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	General, Plastic Surgery	878.4400	2
NEY	SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46421	Rigid endoscopic scissors, reusable	A hand-held rigid device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of stainless steel and is designed as a long pair of parallel sliding arms whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a ringed handle at the proximal end. It is typically introduced into the body cavity through the working channel of the endoscope. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40884524000931	GS1	CASE	10	In Commercial Distribution
Primary	10884524000930	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	10	Centimeter
Device Size Text, specify			tip exposure,2.5,Centimeter;

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 25 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -29 – 149 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 75 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry