Tyvek™ Self-Seal Pouch

GUDID 50732224009006

Tyvek™ Self-Seal Pouch, 3.5"× 5.25"/ 9×13cm

CROSSTEX INTERNATIONAL, INC.

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• Primary Device ID: 50732224009006
• NIH Device Record Key: 3fe18864-b025-45a9-b1b8-1037ecf00241
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tyvek™ Self-Seal Pouch
• Version Model Number: TSP-180
• 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: true
• Expiration Date: false
• 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
• 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	00732224009001 [Unit of Use]
GS1	10732224009008 [Primary]
GS1	50732224009006 [Package]; Contains: 10732224009008; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123162

FDA Product Code

• FRG: Wrap, sterilization

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: 2022-05-11
• Device Publish Date: 2022-05-03

On-Brand Devices [Tyvek™ Self-Seal Pouch]

• 50732224009051: Tyvek™ Self-Seal Pouch, 7.5"× 13"/ 19×33cm
• 50732224009037: Tyvek™ Self-Seal Pouch, 5.25"× 10"/ 13×25cm
• 50732224009013: Tyvek™ Self-Seal Pouch, 3.5"× 9"/ 9×23cm
• 50732224009006: Tyvek™ Self-Seal Pouch, 3.5"× 5.25"/ 9×13cm