MEDICOM SAFEMATRIX

Basic Information

• Brand Name: MEDICOM SAFEMATRIX
• Primary DI: 10686864057151
• Version / Model: 30045
• Catalog Number: 30045
• Company Name: AMD Medicom Inc
• Labeler DUNS: 256880576
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2021-04-27
• Public Version: 1
• Public Version Date: 2021-05-05
• Public Version Status: New
• Public Device Record Key: 853ddf5b-ab67-48ab-8c28-9e3f45c911e9

Device Description

MEDICOM SAFEMATRIX - MATRIX BAND 6 mm Wide

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JEP	Retainer, Matrix	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	20686864057158	GS1	OUTER CASE	8	In Commercial Distribution
Primary	10686864057151	GS1
Unit of Use	00686864057154	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6 mm

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool dry place