Bite Wing-Ease™ Barrier Sleeves

Basic Information

• Brand Name: Bite Wing-Ease™ Barrier Sleeves
• Primary DI: 10732224002986
• Version / Model: BWEL
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Labeler DUNS: 057728685
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2022-09-29
• Public Version: 1
• Public Version Date: 2022-10-07
• Public Version Status: New
• Public Device Record Key: b6cebd4f-2cc7-44ef-9148-0421f8875a8a

Device Description

X-Ray barrier sleeves

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: No
• 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
EGZ	Holder, film, x-ray	Dental	872.1905	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65130	Dental x-ray film holder, single-use	A device designed to stabilize a dental x-ray film intraorally during the taking of a dental x-ray. It is typically an adhesive-backed device designed to fold into a T-shape which adheres to the x-ray film and provides a tab that, when bitten down on, stabilizes the film adjacent to the teeth whilst the x-ray is being taken. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50732224002984	GS1		12	In Commercial Distribution
Primary	10732224002986	GS1
Unit of Use	00732224002989	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K852170	000