Matrix Strips

Basic Information

• Brand Name: Matrix Strips
• Primary DI: 10732224003501
• Version / Model: KSTRIP500
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Labeler DUNS: 057728685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2022-08-19
• Public Version: 1
• Public Version Date: 2022-08-29
• Public Version Status: New
• Public Device Record Key: eda23067-5031-4849-a29f-451196fab749

Device Description

Matrix strips, 4 in x 0.375 in / 10 cm x 0.95 cm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
EKF	INSTRUMENT, CONTOURING, MATRIX, OPERATIVE	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
Package	50732224003509	GS1		12	In Commercial Distribution
Package	30732224003505	GS1		9	In Commercial Distribution
Primary	10732224003501	GS1
Unit of Use	00732224003504	GS1

Customer Contacts

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