Walser® matrices

Basic Information

• Brand Name: Walser® matrices
• Primary DI: 04262363910686
• Version / Model: 029
• Company Name: Dr. Walser Dental GmbH
• Labeler DUNS: 344549605
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-05
• Public Version: 2
• Public Version Date: 2022-12-14
• Public Version Status: Update
• Public Device Record Key: 12648746-5faf-465d-96a0-d0813c5dcdea

Device Description

Set of 18 Walser® matrices with Walser® matrix forceps according to G. R. Daiger

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
DZN	Instruments, Dental Hand	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35851	Rubber dam clamp forceps	A hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissor-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. This is a reusable device.	No	Active
16195	Dental matrix band, reusable	A band or strip of strong material (typically stainless steel or transparent polyester) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is held snugly around the tooth by a matrix retainer or tensioned around the tooth using a dedicated mechanical tensioning device. This is a reusable device.	No	Active
12143	Instrument tray, reusable	A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04262363910686	GS1