Approach Authority Workhorse Microwire Guide

GUDID 00816840020760

HERAEUS MEDICAL COMPONENTS LLC

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual
Primary Device ID00816840020760
NIH Device Record Key49063cf0-0683-4957-b1f6-654d8361154a
Commercial Distribution StatusIn Commercial Distribution
Brand NameApproach Authority Workhorse Microwire Guide
Version Model NumberAUTH-18-190
Company DUNS868303074
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816840020760 [Primary]

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-06-29
Device Publish Date2020-06-19

On-Brand Devices [Approach Authority Workhorse Microwire Guide]

00816840020777AUTH-18-300
00816840020760AUTH-18-190

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.