Dr. Fog® Solution With Sponge

GUDID 00840113200580

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

ASPEN SURGICAL PRODUCTS, INC.

Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution

• Primary Device ID: 00840113200580
• NIH Device Record Key: a2d53eee-c652-43d8-9da6-326ac5cc2860
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr. Fog® Solution With Sponge
• Version Model Number: DF-3100
• 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	00840113200573 [Package]; Contains: 00840113200597; Package: [20 Units]; In Commercial Distribution
GS1	00840113200580 [Package]; Contains: 00840113200573; Package: [15 Units]; In Commercial Distribution
GS1	00840113200597 [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® Solution With Sponge]

• 20887761000067: Intended to be used as an anti-fog agent for endoscopic camera lenses
• 00840113200580: Intended to be used as an anti-fog agent for endoscopic camera lenses