Home GUDID 10724995183643 Guardus
Primary DI 10724995183643
Brand Guardus
Company US Endoscopy
Model 00711149
Catalog number 00711149
Device description 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.
Published 2020-03-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name FED endoscopic access overtube, gastroenterology-urology
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FED Endoscopic Access Overtube, Gastroenterology-Urology Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10724995183643 Package GS1 3 In Commercial Distribution 00816765011232 Previous GS1 0 00724995183646 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10724995183643 10724995183643 00816765011232 00816765011232 816765011232 0816765011232 00724995183646 00724995183646 724995183646 0724995183646
GMDN Terms# Term, Definition table Term Definition Endoscopic overtube, single-use A tubular device intended to be used in combination with a compatible flexible endoscope to aid in endoscopic insertions and to secure a pathway for multiple endoscopic intubations during diagnostic and therapeutic endoscopic procedures (e.g., upper and/or lower gastrointestinal (GI) tract endoscopy). It is a non-steerable, typically single lumen tube constructed of plastic; some types may be "shape locked" into a desired configuration or form to assist in the repeated advancement and withdrawal of the endoscope (e.g., for the removal of multiple polyps and/or foreign bodies). This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 50 Centimeter Lumen/Inner Diameter 17 Millimeter Outer Diameter 19.5 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep Dry Storage Environment Temperature 15 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 627879687 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06936345101536 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345101543 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104469 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104476 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104483 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104490 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104544 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104551 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104568 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06936345104575 Disposable Ureteral Guide Sheath Dongguan ZSR Biomedical Technology Company Limited FED 2026-05-27 06925816667213 ClearPetra Well Lead Medical Co.,Ltd FED 2026-03-16 06925816667220 ClearPetra Well Lead Medical Co.,Ltd FED 2026-03-16 06925816667237 ClearPetra Well Lead Medical Co.,Ltd FED 2026-03-16 06925816657511 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657528 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657535 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657542 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657559 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657566 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657573 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657580 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657597 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657603 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657610 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657627 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657634 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657641 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657658 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657665 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26 06925816657672 ClearPetra Well Lead Medical Co.,Ltd FED 2026-01-26
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