Reusable Interface Cable, 1.5 m

Basic Information

• Brand Name: Reusable Interface Cable, 1.5 m
• Primary DI: 05060359560834
• Version / Model: PRD-IFC-002
• Catalog Number: PRD-IFC-002
• Company Name: CREO MEDICAL LIMITED
• Labeler DUNS: 733853373
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-30
• Public Version: 2
• Public Version Date: 2025-02-10
• Public Version Status: Update
• Public Device Record Key: 173cc0ef-f13a-46cf-9d9e-778338ccc6da

Device Description

The Reusable Interface Cable is only for connection of compatible Creo Medical Instruments (Surgical Accessories) to the CROMA Electrosurgical Generator to deliver Radiofrequency (RF) and/or Microwave energy for the cutting, coagulation and ablation via endoscopic access.

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	05060359560629	GS1
Primary	05060359560834	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1.5	Meter

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 69 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 69 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 20 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 30 Degrees Celsius