winner

GUDID 16941094025016

Winner Medical Co., Ltd.

Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 16941094025016
• NIH Device Record Key: ef3b2189-7ff2-4b66-98f1-25f83eae025c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: winner
• Version Model Number: 604-007415
• Company DUNS: 530629351
• Company Name: Winner Medical Co., Ltd.
• Device Count: 50
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06941094025019 [Unit of Use]
GS1	16941094025016 [Primary]
GS1	26941094025013 [Package]; Package: box [20 Units]; In Commercial Distribution

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-24
• Device Publish Date: 2022-05-16

On-Brand Devices [winner]

• 16941094036166: 604-007965
• 16941094025016: 604-007415
• 16941094064015: 604-006873