STOMA®

Basic Information

• Brand Name: STOMA®
• Primary DI: ESAM818001
• Version / Model: 818.00
• Catalog Number: 818.00
• 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: 1
• Public Version Date: 2020-09-04
• Public Version Status: New
• Public Device Record Key: ac74b482-1777-4278-83a5-f519a056c125

Device Description

Forceps upper molars, left, HP, Fig. 18, Fifo

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
EMG	FORCEPS, TOOTH EXTRACTOR, SURGICAL	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35552	Tooth extraction forceps	A hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	ESAM818000	HIBCC
Primary	ESAM818001	HIBCC

Customer Contacts

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