Home GUDID 00690103192391 EDWARDS DILATOR KIT
Primary DI 00690103192391
Brand EDWARDS DILATOR KIT
Company Edwards Lifesciences LLC
Model 9100DKSA
Catalog number 9100DKSA
Device description EDWARDS DILATOR KIT
Published 2015-12-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Sterile true
Single use true Product Codes# Code, Name table Code Name DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRE Dilator, Vessel, For Percutaneous Catheterization Cardiovascular 2 NPT Aortic Valve, Prosthesis, Percutaneously Delivered Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00690103192391 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 00690103192391 00690103192391 690103192391 0690103192391
GMDN Terms# Term, Definition table Term Definition Vascular catheter introduction set, nonimplantable A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 STORE IN A COOL, DRY PLACE
Regulatory Flags# DUNS number 134139174 Device count 1 Lot or batch 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 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 10884450008925 Prelude® Merit Medical Systems, Inc. DRE 2016-09-24
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