Foley Insertion Tray

GUDID 00616784492735

DYNAREX CORPORATION

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• Primary Device ID: 00616784492735
• NIH Device Record Key: d78bf452-b62f-4ad3-a703-dac2dc719efb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foley Insertion Tray
• Version Model Number: 4927
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784492728 [Unit of Use]
GS1	00616784492735 [Primary]

FDA Product Code

• OHR: Catheter Care Tray

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-04-09
• Device Publish Date: 2016-11-22

On-Brand Devices [Foley Insertion Tray ]

• 00616784492735: 4927
• 00616784492636: 4926