Bite Wing-Ease™ Barrier Sleeves

GUDID 50732224002984

X-Ray barrier sleeves

CROSSTEX INTERNATIONAL, INC.

Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use Dental x-ray film holder, single-use

• Primary Device ID: 50732224002984
• NIH Device Record Key: b6cebd4f-2cc7-44ef-9148-0421f8875a8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bite Wing-Ease™ Barrier Sleeves
• Version Model Number: BWEL
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 50
• DM Exempt: true
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224002989 [Unit of Use]
GS1	10732224002986 [Primary]
GS1	50732224002984 [Package]; Contains: 10732224002986; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K852170

FDA Product Code

• EGZ: Holder, film, x-ray

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-07
• Device Publish Date: 2022-09-29

On-Brand Devices [Bite Wing-Ease™ Barrier Sleeves]

• 50732224002991: X-Ray barrier sleeves
• 50732224002984: X-Ray barrier sleeves