Magic Infusion Catheter

GUDID 00818053022586

Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into selected vessels in the neurovasculature. Magic Infusion Catheters are intended to facilitate access through distant, tortuous vasculature. Progressive suppleness ranging from a highly flexible tip to a semi-rigid proximal section allows the catheter to be advanced by the physician. It is not intended for use in the coronary vasculature.

BALT USA LLC

Vascular microcatheter Vascular microcatheter
Primary Device ID00818053022586
NIH Device Record Key4df6fe7d-c9c9-4b2a-beef-7f3cc06ac561
Commercial Distribution StatusIn Commercial Distribution
Brand NameMagic Infusion Catheter
Version Model NumberMAGIC1.2F
Company DUNS945543689
Company NameBALT USA 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-949-788-1443
Emailcustomerservice@balt-usa.com
Phone1-949-788-1443
Emailcustomerservice@balt-usa.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry place at room temperature and away from light

Device Identifiers

Device Issuing AgencyDevice ID
GS100818053022586 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRACatheter, Continuous Flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-09
Device Publish Date2018-12-01

On-Brand Devices [Magic Infusion Catheter]

00818053022838Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
00818053022821Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
00818053022647Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
00818053022630Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
00818053022623Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
00818053022616Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
00818053022609Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
00818053022593Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into
00818053022586Magic Infusion Catheter is intended to operate for regional infusion of contrast materials into

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