PremierPro TSA High Viscosity Topical Skin Adhesive w/ Mesh 44cm 3473

GUDID 10818566019865

EXOFINFUSION® Skin Closure System, 44cm

SVS LLC

Dermal surgical adhesive/sealant applicator

• Primary Device ID: 10818566019865
• NIH Device Record Key: 39289274-5d2b-4e90-aa39-6a22978a30a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PremierPro TSA High Viscosity Topical Skin Adhesive w/ Mesh 44cm
• Version Model Number: 3473
• Catalog Number: 3473
• 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: 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: 1-855-531-7699
• Email: udi@s2s-global.com
• Phone: 1-855-531-7699
• Email: udi@s2s-global.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818566019868 [Primary]
GS1	10818566019865 [Package]; Contains: 00818566019868; Package: 2/box [3473 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152476

FDA Product Code

• MPN: Tissue Adhesive For The Topical Approximation Of Skin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-30
• Device Publish Date: 2017-10-19

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• 10811220035478 - PremierPro: 2024-03-18 PremierPro Plus Powered by Honeywell Nitrile Exam Glove XLarge 200count
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