Crosstex Surgical Masks with Secure Fit 2.0 Technology

GUDID 50732224005442

Ultra with Secure Fit 2.0 Surgical Mask, Black

CROSSTEX INTERNATIONAL, INC.

Surgical/medical respirator, non-antimicrobial, single-use

• Primary Device ID: 50732224005442
• NIH Device Record Key: 9c1ef117-55b7-4096-b62c-22c94ef94dbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crosstex Surgical Masks with Secure Fit 2.0 Technology
• Version Model Number: GCFBKSF2
• 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
• Phone: +1(585)359-0167
• Email: regulatoryaffairs@hu-friedy.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224005447 [Unit of Use]
GS1	10732224005444 [Primary]
GS1	30732224005448 [Package]; Contains: 10732224005444; Package: [10 Units]; In Commercial Distribution
GS1	50732224005442 [Package]; Contains: 30732224005448; Package: [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103303

FDA Product Code

• FXX: Mask, surgical

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: 2023-09-13
• Device Publish Date: 2023-01-20

On-Brand Devices [Crosstex Surgical Masks with Secure Fit 2.0 Technology]

• 30732224005455: Procedural Secure Fit 2.0 Surgical Mask, Black
• 50732224005442: Ultra with Secure Fit 2.0 Surgical Mask, Black