Unico Global Level 3 Surgical Gown (PP+PE)

GUDID 08809783490235

UNICO GLOBAL INC

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• Primary Device ID: 08809783490235
• NIH Device Record Key: def4cba2-23d2-4b2a-9a4d-7215ca3d88c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unico Global Level 3 Surgical Gown (PP+PE)
• Version Model Number: SG-P2003S-XL
• Company DUNS: 690513726
• Company Name: UNICO GLOBAL INC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809783490235 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203539

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-28
• Device Publish Date: 2022-03-18

On-Brand Devices [Unico Global Level 3 Surgical Gown (PP+PE)]

• 08809783490297: SG-P2004NS-XXL
• 08809783490280: SG-P2004NS-XL
• 08809783490273: SG-P2004NS-L
• 08809783490266: SG-P2004NS-M
• 08809783490259: SG-P2004NS-S
• 08809783490242: SG-P2003S-XXL
• 08809783490235: SG-P2003S-XL
• 08809783490228: SG-P2003S-L
• 08809783490211: SG-P2003S-M
• 08809783490204: SG-P2003S-S