Aximed Prime Soft Shapeable Tip Vascular Guidewire

GUDID 00860009941304

Aximed Prime Soft Shapeable Tip Vascular Guidewire , 0.014", 180cm, Standard (901017- 01-AXI) - 00860009941304

BRIVANT LIMITED

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use
Primary Device ID00860009941304
NIH Device Record Key1fe92a52-90ac-412c-97f7-0218cba11b71
Commercial Distribution StatusIn Commercial Distribution
Brand NameAximed Prime Soft Shapeable Tip Vascular Guidewire
Version Model Number901017- 01-AXI
Company DUNS985303473
Company NameBRIVANT LIMITED
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 Datetrue
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
GS100860009941304 [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 Date2023-07-05
Device Publish Date2023-06-27

On-Brand Devices [Aximed Prime Soft Shapeable Tip Vascular Guidewire]

00860009941328Aximed Prime Soft Shapeable Tip Vascular Guidewire, 0.014", 200cm, Standard (901017-09-AXI) - 00
00860009941311Aximed Prime Soft Shapeable Tip Vascular Guidewire, 0.018", 180cm, Standard (901017- 03-AXI) - 0
00860009941304Aximed Prime Soft Shapeable Tip Vascular Guidewire , 0.014", 180cm, Standard (901017- 01-AXI) -

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