AccuFilm® S050

GUDID M595S0501

AccuFilm® Arch Marking Paper- Red/Blue

PARKELL, INC.

Dental articulation paper

• Primary Device ID: M595S0501
• NIH Device Record Key: 3459f735-a0d1-4508-9374-8d1183a7f802
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AccuFilm®
• Version Model Number: Arch
• Catalog Number: S050
• Company DUNS: 009900424
• Company Name: PARKELL, INC.
• Device Count: 72
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6312491134
• Email: customerservice@parkell.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M595S0500 [Unit of Use]
HIBCC	M595S0501 [Primary]

FDA Product Code

• EFH: Paper, Articulation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-04-01
• Device Publish Date: 2018-10-12

On-Brand Devices [AccuFilm®]

• M595S0532: AccuFilm® II Booklet Red/Black (5 Booklets of 50)
• M595S0501: AccuFilm® Arch Marking Paper- Red/Blue
• 00810000526116: AccuFilm® IV Brush-On Marking Liquid
• 10810000528148: Accu-Film® Fast-Check Double-Sided Blue/Blue
• 00810000526123: Red/Red AccuFilm® II Double-Sided for Korea
• 00810000526109: Black/Black AccuFilm® II Double-Sided for Korea
• 00810000526093: Red/Black AccuFilm® II Double-Sided for Korea
• 00810000526086: Red AccuFilm® I Single-Sided for Korea
• 00810000526680: AccuFilm® IV Brush-On Marking Liquid for Korea
• 20810000526134: AccuFilm® Arch Marking Paper- Red/Blue
• 20810000526141: AccuFilm® II Booklet Red/Black (5 Booklets of 50)
• 10810000526120: Red/Red AccuFilm® II Double-Sided
• 10810000526106: Black/Black AccuFilm® II Double-Sided
• 10810000526090: Red/Black AccuFilm® II Double-Sided
• M595S0151: Red AccuFilm® I Single-Sided
• M595S0141: Black AccuFilm® I Single-Sided