Sure-Check Self-Sealing Sterilization Pouch

GUDID 10732224109425

Self-sealing Sterilization pouch, 5.25 in x 15 in / 13 cm x 38 cm

CROSSTEX INTERNATIONAL, INC.

Sterilization packaging, single-use

• Primary Device ID: 10732224109425
• NIH Device Record Key: c446b88b-f03f-4d34-ad9d-124bccc16688
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sure-Check Self-Sealing Sterilization Pouch
• Version Model Number: SCL5152
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 200
• 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(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com
• Phone: +1(888)276-7783
• Email: crosstex@crosstex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224109428 [Unit of Use]
GS1	10732224109425 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941327

FDA Product Code

• KCT: Sterilization wrap containers, trays, cassettes & other accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-08-06
• Device Publish Date: 2017-02-11

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