SOLO PLUS Stiff Hybrid Guidewires

GUDID 00816840020302

HERAEUS MEDICAL COMPONENTS, LLC

General-purpose non-vascular guidewire
Primary Device ID00816840020302
NIH Device Record Key1c6b1cea-2e91-482c-b453-3d7ca552891e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOLO PLUS Stiff Hybrid Guidewires
Version Model NumberHW38SS
Company DUNS080645456
Company NameHERAEUS MEDICAL COMPONENTS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816840020302 [Primary]

FDA Product Code

EZBStylet For Catheter, Gastro-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-03
Device Publish Date2018-08-01

Devices Manufactured by HERAEUS MEDICAL COMPONENTS, LLC

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00857834006094 - ERCP2018-10-05
00857834006100 - ERCP2018-10-05
00857834006117 - ERCP2018-10-05
00857834006124 - ERCP2018-10-05

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