Steelco

Basic Information

• Brand Name: Steelco
• Primary DI: 08051520011269
• Version / Model: ED 100/2
• Catalog Number: ED 100/2
• Company Name: STEELCO SPA
• Labeler DUNS: 428717469
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-12
• Public Version: 1
• Public Version Date: 2023-09-20
• Public Version Status: New
• Public Device Record Key: abb7772b-64dd-4ec1-bf7e-76e8aaa885d4

Device Description

This device drying cabinet dries and stores flexible endoscopes keeping them in aseptic conditions while waiting for the next patient.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
JRJ	Unit, Drying	Clinical Chemistry	862.2050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45635	Endoscope drying/storage cabinet	An electrically-powered enclosed chamber (the cabinet) designed to dry and store flexible endoscopes and their accessories in an environment that prevents bacterial growth. It uses high-efficiency particulate air (HEPA) inducted into the device and typically heated to 37º Celsius so that the pre-sterilized endoscopes are dried both inside and out. They are then stored within the cabinet under conditions to prevent re-contamination (e.g., under ultraviolet (UV) light) so that they can be directly used without a need for disinfection. It is equipped with a door(s) and shelves to accommodate multiple endoscopes, and is electronically controlled to regulate the drying/storage processes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08051520011269	GS1