Articulating Film

Basic Information

• Brand Name: Articulating Film
• Primary DI: 10732224001835
• Version / Model: TFMBKR
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Labeler DUNS: 057728685
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-09-29
• Public Version: 2
• Public Version Date: 2023-08-25
• Public Version Status: Update
• Public Device Record Key: a44e622a-ca9b-442e-b32a-277909275635
• Distribution End Date: 2023-08-24

Device Description

Articulating Fim, Black-Red Combo,13 µ

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
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	30732224001839	GS1		12	Not in Commercial Distribution	2023-08-24
Primary	10732224001835	GS1
Unit of Use	00732224001838	GS1

Customer Contacts

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