exofin HVTA ST&G, 1g Box of 10 EX70407

GUDID 30854137001147

exofin HVTA ST&G, 1g Box of 10

CHEMENCE MEDICAL PRODUCTS, INC.

Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive Skin-approximation adhesive

• Primary Device ID: 30854137001147
• NIH Device Record Key: b08ce508-2802-4d6b-8937-0162ec0982bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: exofin HVTA ST&G, 1g Box of 10
• Version Model Number: EX70407
• Catalog Number: EX70407
• Company DUNS: 079163089
• Company Name: CHEMENCE MEDICAL PRODUCTS, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	20854137001140 [Primary]
GS1	30854137001147 [Package]; Contains: 20854137001140; Package: Case [60 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-22
• Device Publish Date: 2022-02-14

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