Element Self Sealing Sterilization Pouch 500-00010

GUDID D830500000102

Self Sealing Sterilization Pouch Size: 3.5’’ x 10” (8.9cm x 25.4cm)

GS Medical Packaging Inc

Sterilization packaging, single-use

• Primary Device ID: D830500000102
• NIH Device Record Key: 1dc82f40-8481-475d-835b-471689889d3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Element Self Sealing Sterilization Pouch
• Version Model Number: 500-00010
• Catalog Number: 500-00010
• 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: 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: true

Customer Support Contacts

• Phone: 905.271.1523
• Email: hamed@hedygs.com
• Phone: 905.271.1523
• Email: hamed@hedygs.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D830500000100 [Primary]
HIBCC	D830500000101 [Package]; Contains: D830500000100; Package: Box [200 Units]; In Commercial Distribution
HIBCC	D830500000102 [Package]; Contains: D830500000101; 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: 2019-11-26
• Device Publish Date: 2019-11-18

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"