Marblehead Medical 100240

GUDID 00860003254608

BOSS Balloon Guide Catheter

MARBLEHEAD MEDICAL LLC

Intravascular occluding balloon catheter, image-guided
Primary Device ID00860003254608
NIH Device Record Key474668b0-d1d2-4a74-91c6-3413d9ea03a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameMarblehead Medical
Version Model Number100240
Catalog Number100240
Company DUNS080473303
Company NameMARBLEHEAD MEDICAL 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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003254608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QJPCatheter, Percutaneous, Neurovasculature

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-30
Device Publish Date2020-10-22

On-Brand Devices [Marblehead Medical]

08600032546013BOSS Balloon Guide Catheter
08600032546006BOSS Balloon Guide Catheter, Demo Unit, Not for Human Use
00860003254615BOSS Balloon Guide Catheter, DEMO UNIT, Not for Human Use
00860003254608BOSS Balloon Guide Catheter

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