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

• 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