Guardus 00711148

GUDID 10724995183636

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: 10724995183636
• NIH Device Record Key: e736c48f-c7bf-45e7-9a58-25bfc2f79ec2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guardus
• Version Model Number: 00711148
• Catalog Number: 00711148
• 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

• Lumen/Inner Diameter: 17 Millimeter
• Outer Diameter: 19.5 Millimeter
• Length: 50 Centimeter
• Lumen/Inner Diameter: 17 Millimeter
• Outer Diameter: 19.5 Millimeter
• Length: 50 Centimeter
• Lumen/Inner Diameter: 17 Millimeter
• Outer Diameter: 19.5 Millimeter
• Length: 50 Centimeter
• Lumen/Inner Diameter: 17 Millimeter
• Outer Diameter: 19.5 Millimeter
• Length: 50 Centimeter
• Lumen/Inner Diameter: 17 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	00724995183639 [Primary]
GS1	00816765011225 [Previous]
GS1	10724995183636 [Package]; Contains: 00724995183639; Package: Case [3 Units]; In Commercial Distribution

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: 2020-03-27
• Device Publish Date: 2020-03-19

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