Dual-Force™ Sectional Matrix System Ultra-Wrap Matrix Band Refill Size 5.5mm

Basic Information

• Brand Name: Dual-Force™ Sectional Matrix System Ultra-Wrap Matrix Band Refill Size 5.5mm
• Primary DI: 07540172018890
• Version / Model: 209019
• Catalog Number: 209019
• Company Name: CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
• Labeler DUNS: 626406016
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-12
• Public Version: 1
• Public Version Date: 2021-08-20
• Public Version Status: New
• Public Device Record Key: b25b48cc-a77e-41b9-9878-7f7be009ca9c

Device Description

Dental matrix retainer band

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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZN	INSTRUMENTS, DENTAL HAND	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38786	Dental matrix band, single-use	A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540172018890	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature
• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius