Home GUDID 00813132027445 TightRail Guardian
Primary DI 00813132027445
Brand TightRail Guardian
Company Philips Image Guided Therapy Corporation
Model 575-013
Catalog number 575-013
Device description TightRail Guardian Motorized Dialtor Sheath, 13F
Published 2023-01-10
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name DRE Dilator, Vessel, For Percutaneous Catheterization
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00813132027445 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 00813132027445 00813132027445 813132027445 0813132027445
GMDN Terms# Term, Definition table Term Definition Vascular dilator, single-use A sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Lumen/Inner Diameter 0.171 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep away from sunlight Special Storage Condition, Specify 0 0 Keep dry
Regulatory Flags# DUNS number 118354223 Device count 1 Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10884450706708 Prelude® Merit Medical Systems, Inc. DRE 2026-06-03 10884450415358 Prelude® Merit Medical Systems, Inc. DRE 2026-05-28 10841156105921 VSI TELEFLEX INCORPORATED DRE 2020-02-06 10841156105945 VSI TELEFLEX INCORPORATED DRE 2020-02-06 10841156105907 VSI TELEFLEX INCORPORATED DRE 2020-01-27 10841156105914 VSI TELEFLEX INCORPORATED DRE 2020-01-27 10841156105938 VSI TELEFLEX INCORPORATED DRE 2020-01-27 10841156105952 VSI TELEFLEX INCORPORATED DRE 2020-01-27 08714729295822 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729295839 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729295853 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729375555 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 08714729742913 NA BOSTON SCIENTIFIC CORPORATION DRE 2016-09-24 10827002237374 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002237466 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002237473 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002465395 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002465401 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10827002465418 Evolution Cook Vandergrift Inc. DRE 2016-09-24 10884450007829 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450007867 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450007904 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008086 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008109 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008147 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008857 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008871 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008888 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008895 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24 10884450008901 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24
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