STOMA®

Basic Information

• Brand Name: STOMA®
• Primary DI: ESAM5355101
• Version / Model: 5355.10
• Catalog Number: 5355.10
• Company Name: Storz am Mark GmbH
• Labeler DUNS: 318268125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-27
• Public Version: 1
• Public Version Date: 2020-09-04
• Public Version Status: New
• Public Device Record Key: 3d78086f-b40f-4a17-b88c-cf0abf8cbfcf

Device Description

Crown scissors sharp, curved, 10cm

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EIR	SCISSORS, COLLAR AND CROWN	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31847	Dental collar/crown scissors	A hand-held dental instrument designed to cut metal bands. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has short, robust, blades that can cut through the thin metal strips (bands). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	ESAM5355100	HIBCC
Primary	ESAM5355101	HIBCC

Customer Contacts

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