STERIS

Basic Information

• Brand Name: STERIS
• Primary DI: 00817688023562
• Version / Model: SSESHR02
• Catalog Number: SSESHR02
• Company Name: I.C. MEDICAL, INC.
• Labeler DUNS: 616182895
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2021-10-19
• Public Version: 1
• Public Version Date: 2021-10-27
• Public Version Status: New
• Public Device Record Key: c882f1ee-63f2-4bc7-836c-7b64ce93faf0

Device Description

ICM-000-0648 STERIS ESU Shroud, Short Tip, & 9 Foot Tube, Non-Sterile, Bulk

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: 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46483	Surgical plume evacuation system tube	A sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00817688023555	GS1
Primary	00817688023562	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