SCHWERT

Basic Information

• Brand Name: SCHWERT
• Primary DI: E8963409100S0
• Version / Model: 3409-100S
• Catalog Number: 3409-100S
• Company Name: A. Schweickhardt GmbH & Co. KG
• Labeler DUNS: 341195628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-22
• Public Version: 1
• Public Version Date: 2023-03-02
• Public Version Status: New
• Public Device Record Key: 86c86ad4-d43c-4d8c-8618-2c56d1db05eb

Device Description

OPTIFLEX Plastic perio probes insert assorted each figure 2 pieces

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: Yes
• 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
EIX	PROBE, PERIODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41660	Periodontal curette	A hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E8963409100S0	HIBCC

Customer Contacts

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