Home GUDID M204555511AA0 SightRail™
Primary DI M204555511AA0
Brand SightRail™
Company Spectranetics Corporation
Model 555-511AA
Catalog number 555-511
Device description SightRail™ Manual Dilator Sheath
Published 2015-02-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
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 00813132020965 Primary GS1 0 M204555511AA0 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00813132020965 00813132020965 813132020965 0813132020965
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 0.147 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Keep Dry Storage Environment Temperature 0 Degrees Fahrenheit 140 Degrees Fahrenheit
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 151047370 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use 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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