MedSource Isolation Gown Not Applicable

GUDID 00816703023013

Isolation Gown, Yellow

MEDSOURCE INTERNATIONAL LLC

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• Primary Device ID: 00816703023013
• NIH Device Record Key: 6d5da0ee-0461-4b0c-a348-e3a50d4fd73c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedSource Isolation Gown
• Version Model Number: 315748REG
• Catalog Number: Not Applicable
• Company DUNS: 041674552
• Company Name: MEDSOURCE INTERNATIONAL LLC
• Device Count: 1
• 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: false
• Donation Id Number: true
• 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	00816703023006 [Primary]
GS1	00816703023013 [Package]; Contains: 00816703023006; Package: Case [100 Units]; In Commercial Distribution

FDA Product Code

• OEA: Non-Surgical Isolation Gown

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: 2021-04-27
• Device Publish Date: 2021-04-19

On-Brand Devices [MedSource Isolation Gown]

• 00816703023013: Isolation Gown, Yellow
• 00840155400641: Yellow Isolation Gown
• 00840155400610: Isolation Gown, Yellow, Adult