PROFESSIONAL'S CHOICE

GUDID D8304410161

PROFESSIONAL'S CHOICE 10"X16"D

GS Medical Packaging Inc

Sterilization packaging, single-use

• Primary Device ID: D8304410161
• NIH Device Record Key: c19e66da-1b04-400a-bbc0-6f226338d22d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROFESSIONAL'S CHOICE
• Version Model Number: 441016
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D830441016 [Primary]
HIBCC	D8304410161 [Package]; Contains: D830441016; Package: CARDBOARD BOX [200 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