STERIS

Basic Information

• Brand Name: STERIS
• Primary DI: 00817688023685
• Version / Model: SSEPEN13
• Catalog Number: SSEPEN13
• Company Name: I.C. MEDICAL, INC.
• Labeler DUNS: 616182895
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-11
• Public Version: 1
• Public Version Date: 2022-05-19
• Public Version Status: New
• Public Device Record Key: 5905338e-8caf-4482-9ba9-d38a4a5a18b4

Device Description

ICM-000-0658 STERIS Non-Telescopic ESU Pencil, Stainless Steel ENT Needle, 10 Foot Tube & Holster, Sterile

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: Yes
• MRI Safety: MR Unsafe
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
61869	Open-surgery electrosurgical handpiece/electrode, monopolar, single-use	A rigid device consisting of combined electrosurgical handpiece and monopolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. This is a single-use device intended to be used in a sterile condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00817688023692	GS1		20	In Commercial Distribution
Primary	00817688023685	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity