Plus Medical Cover Gown

GUDID 16973062321400

Foshan Nanhai Plus Medical Co., Ltd

Surgical gown, single-use

• Primary Device ID: 16973062321400
• NIH Device Record Key: 9122c7e3-088f-4ffe-af7e-3cc1ffdacab8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plus Medical Cover Gown
• Version Model Number: PM4405PG
• Company DUNS: 529796225
• Company Name: Foshan Nanhai Plus Medical Co., Ltd
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973062321403 [Primary]
GS1	16973062321400 [Package]; Contains: 06973062321403; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213177

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

[16973062321400]

Ethylene Oxide

[16973062321400]

Ethylene Oxide

[16973062321400]

Ethylene Oxide

[16973062321400]

Ethylene Oxide

[16973062321400]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-25
• Device Publish Date: 2022-05-17

On-Brand Devices [Plus Medical Cover Gown ]

• 16973062321431: PM4408PG
• 16973062321424: PM4407PG
• 16973062321417: PM4406PG
• 16973062321400: PM4405PG
• 16973062321394: PM4404PG
• 16973062321387: PM4403PG
• 16973062321370: PM4402PG
• 16973062321363: PM4401PG