AccuFilm®

Basic Information

• Brand Name: AccuFilm®
• Primary DI: 10810000526137
• Version / Model: Arch
• Catalog Number: S050
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2018-10-19
• Public Version: 3
• Public Version Date: 2023-12-25
• Public Version Status: Update
• Public Device Record Key: 0b56e1c6-16af-4cc1-b923-210d832ef24a
• Distribution End Date: 2021-09-30

Device Description

AccuFilm® Arch Marking Paper- Red/Blue

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
EFH	Paper, Articulation	Dental	872.6140	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16181	Dental articulation paper	A strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20810000526134	GS1	Box	6	Not in Commercial Distribution	2021-09-30
Primary	10810000526137	GS1
Unit of Use	00810000526130	GS1

Customer Contacts

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