Edge

Basic Information

• Brand Name: Edge
• Primary DI: 10884521175549
• Version / Model: E1465-4NSB
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2022-05-23
• Public Version Status: Update
• Public Device Record Key: 554e8a3d-b78f-4f62-b9f6-82aae8848e97
• Distribution End Date: 2018-02-24

Device Description

Insulated Needle Electrode

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: Yes
• 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
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61875	Endoscopic electrosurgical electrode, monopolar, single-use	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10884521175549	GS1
Unit of Use	20884521175546	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K981916	000

Device Sizes

Type	Value	Unit	Text
Length	4	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry
• Type: Handling Environment Temperature
• Temperature Range: -29 – 149 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 0 – 75 Percent (%) Relative Humidity