remOVE FBR Set 400.05

GUDID 04260206310778

The remOVE FBR Set is a foreign body retrieval set for flexible endoscopy • safe removal of ingested foreign objects • it consists of the following products: remOVE SecureCap 12 (elastic and transparent retrieval cap) • remOVE Grasper (specially designed grasping forceps | alligator and rat teeth for strong hold and easy retrieval of foreign bodies into the remOVE Secure Cap)

Ovesco Endoscopy AG

Flexible endoscopic tissue manipulation forceps, single-use

• Primary Device ID: 04260206310778
• NIH Device Record Key: ad673a45-404d-428a-9233-0e95e3faa4ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: remOVE FBR Set
• Version Model Number: 12
• Catalog Number: 400.05
• Company DUNS: 344007369
• Company Name: Ovesco Endoscopy AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: +49707196528160
• Email: service@ovesco.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260206310778 [Package]; Contains: 04260206310785; Package: folding box [2 Units]; In Commercial Distribution
GS1	04260206310785 [Primary]

FDA Product Code

• KOA: Surgical Instruments, G-U, Manual (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-31
• Device Publish Date: 2018-10-02

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