Anti-Fog Kit AF-100

GUDID 00690521014633

Anti-Fog Solution, 6 g solution, 1 sponge, pouch

Batrik Medical Manufacturing Inc

Endoscopic antifog solution

• Primary Device ID: 00690521014633
• NIH Device Record Key: fffa34ed-34e9-41e1-91a1-07187a5d9971
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anti-Fog Kit
• Version Model Number: AF-100
• Catalog Number: AF-100
• Company DUNS: 243880700
• Company Name: Batrik Medical Manufacturing 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Weight: 6 Gram
• Weight: 6 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690521014626 [Primary]
GS1	00690521014633 [Package]; Contains: 00690521014626; Package: BOX [20 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-30
• Device Publish Date: 2018-06-29

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