Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)

GUDID 08809783490105

UNICO GLOBAL INC

Surgical gown, single-use

• Primary Device ID: 08809783490105
• NIH Device Record Key: 328e9170-ca0e-4dd0-acb6-13f8cb555ae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Unico Global Level 3 Surgical Gown (Film-Reinforced SMS)
• Version Model Number: SG-S2001S-S
• 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	08809783490105 [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 (Film-Reinforced SMS)]

• 08809783490198: SG-S2002NS-XXL
• 08809783490181: SG-S2002NS-XL
• 08809783490174: SG-S2002NS-L
• 08809783490167: SG-S2002NS-M
• 08809783490150: SG-S2002NS-S
• 08809783490143: SG-S2001S-XXL
• 08809783490136: SG-S2001S-XL
• 08809783490129: SG-S2001S-L
• 08809783490112: SG-S2001S-M
• 08809783490105: SG-S2001S-S