Surgical Gowns

GUDID 00616784819532

DYNAREX CORPORATION

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• Primary Device ID: 00616784819532
• NIH Device Record Key: 781c8c25-64dd-440e-8b35-5a3cef23ad78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Gowns
• Version Model Number: 8195
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 20
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784819518 [Unit of Use]
GS1	00616784819532 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111067

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-24

On-Brand Devices [Surgical Gowns]

• 00616784819532: 8195
• 00616784819433: 8194
• 00616784819334: 8193
• 00616784819235: 8192