PremierPro 4045

GUDID 10854344002537

PremierPro Powder Free Vinyl Exam Glove Standard X-Large 100 count

SVS LLC

Vinyl examination/treatment glove, non-powdered

• Primary Device ID: 10854344002537
• NIH Device Record Key: 1cd2af3d-6fc1-42d5-9609-ea767e12e424
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PremierPro
• Version Model Number: 4045
• Catalog Number: 4045
• Company DUNS: 831375089
• Company Name: SVS LLC
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-855-531-7699
• Email: info@s2s-global.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854344002530 [Primary]
GS1	10854344002537 [Package]; Contains: 00854344002530; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100326

FDA Product Code

• LYZ: Vinyl Patient Examination Glove

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: 2020-07-02
• Device Publish Date: 2020-06-24

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