Premium Non-Woven Sponges ENCNW4K

GUDID 50732224005206

2" x 2", 4-Ply

CROSSTEX INTERNATIONAL, INC.

Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad Non-woven gauze pad

• Primary Device ID: 50732224005206
• NIH Device Record Key: 5030a444-84a1-4f07-92ff-94f3be22ac3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premium Non-Woven Sponges
• Version Model Number: ENCNW4K
• Catalog Number: ENCNW4K
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 200
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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	00732224005201 [Unit of Use]
GS1	10732224005208 [Primary]
GS1	50732224005206 [Package]; Contains: 10732224005208; Package: case [10 Units]; In Commercial Distribution

FDA Product Code

• NAB: Gauze / sponge,nonresorbable for external use

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: 2023-07-25
• Device Publish Date: 2023-07-17

Devices Manufactured by CROSSTEX INTERNATIONAL, INC.

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• 20815878025321 - Burkhart Non-Woven Sponges: 2024-04-17
• 20815878027585 - Burkhart Non-Woven Sponges: 2024-04-17
• 20815878027592 - Burkhart Cotton Rolls: 2024-04-17
• 20815878028483 - Burkhart Non-Woven Sponges: 2024-04-17
• 10732224005673 - DentaPure Water Purification Bottle Cartridge: 2024-04-16 International Water Purification Bottle Cartridge
• 10732224005680 - DentaPure Water Purification Municipal Cartridge: 2024-04-16 International Water Purification Municipal Cartridge