Burkhart Non-Woven Sponges

GUDID 20815878027585

CROSSTEX INTERNATIONAL, INC.

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• Primary Device ID: 20815878027585
• NIH Device Record Key: 745a8aaf-df72-49ab-8bee-04873b765828
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burkhart Non-Woven Sponges
• Version Model Number: ENC100BK
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 200
• DM Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815878027581 [Unit of Use]
GS1	10815878027588 [Primary]
GS1	20815878027585 [Package]; Contains: 10815878027588; Package: Case [25 Units]; In Commercial Distribution

FDA Product Code

• EFN: COTTON, ROLL

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: 2024-04-17
• Device Publish Date: 2024-04-09

On-Brand Devices [Burkhart Non-Woven Sponges]

• 20815878028483: ENC4NWLBK
• 20815878027585: ENC100BK
• 20815878025321: ENCNWLBK