F14-040300-090 F14-040300-090

GUDID 06942265502155

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic
Primary Device ID06942265502155
NIH Device Record Key2f054967-df74-472b-9889-d137ff9c8fa9
Commercial Distribution StatusIn Commercial Distribution
Brand NameF14-040300-090
Version Model Numberrev 01
Catalog NumberF14-040300-090
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
GS106942265502155 [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 Date2025-05-19
Device Publish Date2025-05-09

Devices Manufactured by BrosMed Medical Co.,Ltd.

06942265520807 - Parafleet SC 035 PTA Balloon Dilatation Catheter2025-05-21
06942265502018 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-19
06942265502025 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-19
06942265502032 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-19
06942265502049 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-19
06942265502056 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-19
06942265502063 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-19
06942265502070 - Parafleet SC 014 PTA Balloon Dilatation Catheter2025-05-19

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