Spring Coil Guidewire

GUDID 00857834006391

HERAEUS MEDICAL COMPONENTS, LLC

Cardiac/peripheral vascular guidewire, single-use
Primary Device ID00857834006391
NIH Device Record Key70be5e74-53c4-4b4d-bdad-e29a4d2867d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpring Coil Guidewire
Version Model NumberSCG-005
Company DUNS080645456
Company NameHERAEUS MEDICAL COMPONENTS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100857834006391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-21

On-Brand Devices [Spring Coil Guidewire]

00857834006391SCG-005
00857834006063SCG-004
00857834006056SCG-003
00857834006049SCG-002
00857834006032SCG-001

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