Professional's Choice

GUDID D8304420901

Professional's Choice Self Seal Sterilization Pouch Size 2.75"X10"

GS Medical Packaging Inc

Sterilization packaging, single-use

• Primary Device ID: D8304420901
• NIH Device Record Key: cf0805b2-d8e0-4628-8fd2-4f0d9d3681c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Professional's Choice
• Version Model Number: 442090
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 9052711523
• Email: accounting@gsmedicalpackaging.com
• Phone: 9052711523
• Email: accounting@gsmedicalpackaging.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D830442090 [Primary]
HIBCC	D8304420901 [Package]; Contains: D830442090; Package: cardboard box [200 Units]; In Commercial Distribution
HIBCC	D8304420902 [Package]; Package: [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-10-06