STOMA®

Basic Information

• Brand Name: STOMA®
• Primary DI: ESAM12962001
• Version / Model: 12962.00
• Catalog Number: 12962.00
• 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: 2
• Public Version Date: 2020-12-04
• Public Version Status: Update
• Public Device Record Key: 04c3216c-b610-4b66-9833-124e15e793c4

Device Description

Periotome, straight/curved on theedge, Ø 8mm

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
EMO	KNIFE, PERIODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45713	Periotome, reusable	A hand-held dental instrument intended to be used during tooth extraction/luxation to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process), causing minimal mechanical trauma to the bone tissue. It is typically made of stainless steel and consists of a shaft that terminates in a single or double flat, sharpened blade that is straight, curved, or angled. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	ESAM12962000	HIBCC
Primary	ESAM12962001	HIBCC

Customer Contacts

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