MedPride Reinforced Surgical Gowns 70284

GUDID 10352410702843

Surgical Gown Sterile Medium

SHIELD-LINE, LLC

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• Primary Device ID: 10352410702843
• NIH Device Record Key: 3a56d966-8b76-432d-9ba4-13508699fd76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedPride Reinforced Surgical Gowns
• Version Model Number: 70284
• Catalog Number: 70284
• Company DUNS: 078518916
• Company Name: SHIELD-LINE, LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00352410702846 [Unit of Use]
GS1	10352410702843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101593

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: 3
• Public Version Date: 2020-02-21
• Device Publish Date: 2018-08-30

On-Brand Devices [MedPride Reinforced Surgical Gowns ]

• 10352410702867: Surgical Gown Sterile Extra Large Size
• 10352410702850: Surgical Gown Reinforced Size large Sterile unless the package is opened or damaged
• 10352410702843: Surgical Gown Sterile Medium
• 00352410702877: Surgical Gown Sterile XXL Size