STERILIZATION BOX

Basic Information

• Brand Name: STERILIZATION BOX
• Primary DI: 07899995206633
• Version / Model: COSW 02
• Catalog Number: COSW 02
• Company Name: Sin Sistema de Implante Nacional S/A
• Labeler DUNS: 904569092
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-22
• Public Version: 2
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: fa900a26-6c53-4a03-857a-26ed9af9cbf9

Device Description

ORGANIZER BOX STRONG SW

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• 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: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16349	Instrument transport trolley system	A combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07899995206633	GS1

Premarket Submissions

Submission Number	Supplement Number
K201688	000