STOMA®

Basic Information

• Brand Name: STOMA®
• Primary DI: ESAM13321181
• Version / Model: 13321.18
• Catalog Number: 13321.18
• 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: ee878f67-8fa6-4bd9-a145-dff1d72418a8

Device Description

Osteotome, 8mm, graduated on both sides, angled

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
EML	CHISEL, BONE, SURGICAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44887	Dental osteotome	A hand-held, dental, surgical instrument used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. It is hand-held by the dentist who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The device will have a straight or bayonet-shaped handle leading to a round or concave tip at the distal end, which may be marked with graduations to indicate depth differences. It is used for ridge expanding, bone condensing and sinus floor elevation procedures. This device will be made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	ESAM13321180	HIBCC
Primary	ESAM13321181	HIBCC

Customer Contacts

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