Parafleet SC 035PTA Balloon Dilatation Catheter F35-070030-200

GUDID 06942265520852

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic
Primary Device ID06942265520852
NIH Device Record Keya26544f3-422b-4a31-b57d-c28e3c63b7e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameParafleet SC 035PTA Balloon Dilatation Catheter
Version Model Numberrev 02
Catalog NumberF35-070030-200
Company DUNS421318800
Company NameBrosMed Medical Co.,Ltd.
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
GS106942265520852 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, Angioplasty, Peripheral, Transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-05-15
Device Publish Date2025-05-07

Devices Manufactured by BrosMed Medical Co.,Ltd.

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06942265500830 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-16
06942265500847 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-16
06942265500854 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-16
06942265500861 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-16
06942265500878 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-16
06942265500885 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-16
06942265500892 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-16

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