Guardus SI711147

GUDID 00724995184490

The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tissue retrieval, and/or for endoscopic procedures requiring multiple endoscope intubations.

US Endoscopy

Endoscopic overtube, single-use

• Primary Device ID: 00724995184490
• NIH Device Record Key: 03c831ff-1e40-49ba-a4ed-3afa97cd7be6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardus
• Version Model Number: SI711147
• Catalog Number: SI711147
• Company DUNS: 627879687
• Company Name: US Endoscopy
• 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: 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: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Dimensions

• Outer Diameter: 19.5 Millimeter
• Lumen/Inner Diameter: 17 Millimeter
• Length: 25 Centimeter
• Outer Diameter: 19.5 Millimeter
• Lumen/Inner Diameter: 17 Millimeter
• Length: 25 Centimeter
• Outer Diameter: 19.5 Millimeter
• Lumen/Inner Diameter: 17 Millimeter
• Length: 25 Centimeter
• Outer Diameter: 19.5 Millimeter
• Lumen/Inner Diameter: 17 Millimeter
• Length: 25 Centimeter
• Outer Diameter: 19.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995184490 [Primary]
GS1	10816765012038 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040836

FDA Product Code

• FED: endoscopic access overtube, gastroenterology-urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-10
• Device Publish Date: 2020-04-02

On-Brand Devices [Guardus]

• 10816765011239: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 10816765011222: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 10816765011215: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 10816765011208: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 10816765012052: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 10816765012045: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 10816765012038: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 10816765012021: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 10724995183643: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 10724995183636: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 10724995183629: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 10724995183612: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 00724995184506: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 00724995184490: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis
• 00724995184483: The disposable overtube is used in conjunction with a flexible endoscope for foreign body or tis