Syvek Patch

GUDID 10389142000084

Syvek is a 3 cm x 3 cm patch used for vascular hemostasis

MARINE POLYMER TECHNOLOGIES, INC.

Plant polysaccharide haemostatic agent, non-bioabsorbable

• Primary Device ID: 10389142000084
• NIH Device Record Key: dfcc62fb-3325-4826-8800-c9ee62f966ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syvek Patch
• Version Model Number: 400-02
• Company DUNS: 809739386
• Company Name: MARINE POLYMER TECHNOLOGIES, 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: false
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-666-2560
• Email: pattid@webmpt.com
• Phone: 1-888-666-2560
• Email: pattid@webmpt.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00389142000087 [Primary]
GS1	10389142000084 [Package]; Contains: 00389142000087; Package: Box [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984177

FDA Product Code

• KMF: Bandage, Liquid

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: 2020-01-28
• Device Publish Date: 2020-01-20

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