NA

Basic Information

• Brand Name: NA
• Primary DI: 10724995003071
• Version / Model: 886118
• Catalog Number: 886118
• Company Name: STERIS CORPORATION
• Labeler DUNS: 961394798
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2017-01-17
• Public Version: 11
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: ada05b84-cac0-4439-95e0-e52aa2ded5e6

Device Description

The Vis-U-All Low Temperature Self Seal Pouch is used in the V-PRO Low Temperature Sterilization Systems and STERRAD NX, 100S and 100NX sterilizers.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
FRG	Wrap, sterilization	General Hospital	880.6850	2
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	50724995003079	GS1	Case	4	In Commercial Distribution
Primary	10724995003071	GS1
Unit of Use	00724995003074	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K070765	000
K071087	000
K090371	000
K092745	000
K140487	000
K160908	000
K172749	000
K183297	000
K183401	000
K222440	000
K231500	000

Device Sizes

Type	Value	Unit	Text
Length	18	Inch
Width	12	Inch