Element Self Sealing Sterilization Pouch 500-0008

GUDID D83050000081

Self Sealing Sterilization Pouch 3.5"X5.5"

GS Medical Packaging Inc

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• Primary Device ID: D83050000081
• NIH Device Record Key: d9a98556-3dd4-4ae4-9548-b20dc6ed7344
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Element Self Sealing Sterilization Pouch
• Version Model Number: 500-0008
• Catalog Number: 500-0008
• Company DUNS: 246113039
• Company Name: GS Medical Packaging Inc
• Device Count: 1
• DM Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com
• Phone: 905.271.1523
• Email: HamedTaherie@gsmedicalpackaging.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8305000008 [Primary]
HIBCC	D83050000081 [Package]; Contains: D8305000008; Package: BOX [200 Units]; In Commercial Distribution
HIBCC	D83050000082 [Package]; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K953829

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-23
• Device Publish Date: 2020-10-15

On-Brand Devices [Element Self Sealing Sterilization Pouch]

• D830500000112: Self Sealing Sterilization Pouch 5.25’’ x 10” (13.3 cm x 25.4 cm)
• D830500000102: Self Sealing Sterilization Pouch Size: 3.5’’ x 10” (8.9cm x 25.4cm)
• D830500000091: Self Sealing Sterilization Pouch 2.75’’ x 10”
• D83050000081: Self Sealing Sterilization Pouch 3.5"X5.5"