Dr. Fog® Anti-fog Solution

GUDID 00840113200603

Intended to be used as an anti-fog agent for endoscopic camera lenses

ASPEN SURGICAL PRODUCTS, INC.

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• Primary Device ID: 00840113200603
• NIH Device Record Key: f3b5c1d2-754e-47c7-a8f1-c1d9a3ede9ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr. Fog® Anti-fog Solution
• Version Model Number: DF-3100B
• Company DUNS: 027680821
• Company Name: ASPEN SURGICAL 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com
• Phone: +1(616)698-7100
• Email: customerservice@aspensurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840113200603 [Package]; Contains: 00840113200627; Package: [20 Units]; In Commercial Distribution
GS1	00840113200627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932449

FDA Product Code

• OCT: Anti fog solution and accessories, endoscopy

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: 2021-03-05
• Device Publish Date: 2021-02-25

On-Brand Devices [Dr. Fog® Anti-fog Solution]

• 20887761000036: Intended to be used as an anti-fog agent for endoscopic camera lenses
• 00840113200603: Intended to be used as an anti-fog agent for endoscopic camera lenses