Ensure Sterilization Pouch

Basic Information

• Brand Name: Ensure Sterilization Pouch
• Primary DI: 17540196001653
• Version / Model: SCI-SCP
• Catalog Number: SCI-SCP
• Company Name: Scican Ltd
• Labeler DUNS: 204137145
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2018-08-30
• Public Version: 4
• Public Version Date: 2022-11-14
• Public Version Status: Update
• Public Device Record Key: 7ed042d6-6a7b-4593-aa34-625884b0c50f
• Distribution End Date: 2022-03-01

Device Description

Self-sealing sterilization pouches with internal and external multi-variable (parameter) chemical indicator

Device Characteristics

• Single Use: Yes
• 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: 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: No
• Sterilization Prior Use: No

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
13735	Sterilization packaging, single-use	A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27540196001650	GS1	Carton	20	Not in Commercial Distribution	2022-03-01
Primary	17540196001653	GS1
Unit of Use	07540196001656	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K941327	000