AccuFilm®

Basic Information

• Brand Name: AccuFilm®
• Primary DI: 10810000528148
• Version / Model: S054
• Catalog Number: S054
• Company Name: PARKELL, INC.
• Labeler DUNS: 009900424
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2019-07-26
• Public Version: 7
• Public Version Date: 2023-12-20
• Public Version Status: Update
• Public Device Record Key: 87f0ced3-40a1-42e3-b06c-55c44dec516e

Device Description

Accu-Film® Fast-Check Double-Sided Blue/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: Yes
• Has Manufacturing Date: Yes
• 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
Primary	10810000528148	GS1
Unit of Use	00810000528141	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius