Nuvaderm

GUDID 00866349000404

CHESSON LABORATORY ASSOCIATES, INC

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• Primary Device ID: 00866349000404
• NIH Device Record Key: 71243bde-9a91-4661-bba6-8517f8f9ab93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nuvaderm
• Version Model Number: Non-Sterile
• Company DUNS: 946203481
• Company Name: CHESSON LABORATORY ASSOCIATES, 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866349000404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083913

FDA Product Code

• KMF: Bandage, Liquid

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: 2018-08-02
• Device Publish Date: 2018-07-02

On-Brand Devices [Nuvaderm]

• 00086634900040: Non-Sterile
• 00866349000404: Non-Sterile