Dr. Fog® Treated Sponge

GUDID 10887761000053

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 Endoscopic antifog solution Endoscopic antifog solution Endoscopic antifog solution

• Primary Device ID: 10887761000053
• NIH Device Record Key: 74c9c7ea-72ff-42f9-bf2a-c31307205ef9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dr. Fog® Treated Sponge
• Version Model Number: DF-3120
• 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
• 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	00887761000056 [Primary]
GS1	10887761000053 [Package]; Contains: 00887761000056; Package: [20 Units]; In Commercial Distribution
GS1	20887761000050 [Package]; Package: [2 Units]; In Commercial Distribution
GS1	30887761000057 [Package]; Contains: 20887761000050; Package: [12 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-18
• Device Publish Date: 2016-09-17

On-Brand Devices [Dr. Fog® Treated Sponge]

• 10887761000077: Intended to be used as an anti-fog agent for endoscopic camera lenses
• 10887761000053: Intended to be used as an anti-fog agent for endoscopic camera lenses
• 00840113206957: Intended to be used as an anti-fog agent for endoscopic camera lenses
• 00840113206902: Intended to be used as an anti-fog agent for endoscopic camera lenses