G.O.L.F.F. Glasses or Lenses Fog Free G.O.L.F.F.

GUDID 00690521013728

Anti-Fog Solution Pouch with 6 g solution and adhesive sponge.

Batrik Medical Manufacturing Inc

Endoscopic antifog solution

• Primary Device ID: 00690521013728
• NIH Device Record Key: 07f7cb0a-189d-4870-bc31-b51f0094aaec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G.O.L.F.F. Glasses or Lenses Fog Free
• Version Model Number: G.O.L.F.F.
• Catalog Number: G.O.L.F.F.
• 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

Customer Support Contacts

• Phone: 18006615432
• Email: kreid@surmged.com
• Phone: 18006615432
• Email: kreid@surmged.com

Device Dimensions

• Weight: 6 Gram
• Weight: 6 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690521000643 [Package]; Package: BOX [20 Units]; In Commercial Distribution
GS1	00690521013728 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-06

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