T-Edge 11

Basic Information

• Brand Name: T-Edge 11
• Primary DI: 07290110640705
• Version / Model: AMS11-120-T
• Catalog Number: AMS11-120-T
• Company Name: TUTTNAUER ISRAEL LTD.
• Labeler DUNS: 600030209
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-11
• Public Version: 2
• Public Version Date: 2022-01-10
• Public Version Status: Update
• Public Device Record Key: 9aa96cf1-1f05-4d44-8553-4f7b7b69c8f5

Device Description

Sterilizer,steam

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: No
• 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
FLE	Sterilizer, Steam	General Hospital	880.6880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38671	Steam sterilizer	A mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products using pressurized steam (i.e., moist heat) as the sterilizing agent; it is used for products non-sensitive to high temperature, water, or steam. It typically includes a treatment chamber with shelves for device placement, and controls; it may be intended to sterilize wrapped and/or unwrapped devices. The device is available in a variety of shapes and sizes, including stand-alone (bulk) and tabletop units.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290110640705	GS1

Premarket Submissions

Submission Number	Supplement Number
K143311	000
K213080	000