Flexible Overtube

GUDID 04545499070098

Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.

SUMITOMO BAKELITE COMPANY LIMITED

Endoscopic overtube, single-use

• Primary Device ID: 04545499070098
• NIH Device Record Key: cc9e2b9a-a53e-4d78-92a7-72be66e976f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexible Overtube
• Version Model Number: MD-48719
• Company DUNS: 690551106
• Company Name: SUMITOMO BAKELITE COMPANY LIMITED
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Lumen/Inner Diameter: 16 Millimeter
• Length: 205 Millimeter
• Outer Diameter: 19 Millimeter
• Lumen/Inner Diameter: 16 Millimeter
• Length: 205 Millimeter
• Outer Diameter: 19 Millimeter
• Lumen/Inner Diameter: 16 Millimeter
• Length: 205 Millimeter
• Outer Diameter: 19 Millimeter
• Lumen/Inner Diameter: 16 Millimeter
• Length: 205 Millimeter
• Outer Diameter: 19 Millimeter
• Lumen/Inner Diameter: 16 Millimeter
• Length: 205 Millimeter
• Outer Diameter: 19 Millimeter
• Length: 205 Millimeter
• Outer Diameter: 19 Millimeter
• Length: 205 Millimeter
• Outer Diameter: 19 Millimeter
• Length: 205 Millimeter
• Outer Diameter: 19 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04545499070098 [Primary]
GS1	24545499070092 [Package]; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182520

FDA Product Code

• FED: Endoscopic Access Overtube, Gastroenterology-Urology

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: 2019-10-01
• Device Publish Date: 2019-09-23

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• 04545499070098 - Flexible Overtube: 2019-10-01Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.
• 04545499070098 - Flexible Overtube: 2019-10-01 Flexible Overtube is a device used in conjunction with a flexible endoscope for tissue or foreign body retrieval, and/or for end