Parafleet SC 014PTA Balloon Dilatation Catheter F14-060100-120

GUDID 06942265504135

BrosMed Medical Co.,Ltd.

Peripheral angioplasty balloon catheter, basic
Primary Device ID06942265504135
NIH Device Record Key0a323d19-025a-4702-929d-ce84809c5bcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameParafleet SC 014PTA Balloon Dilatation Catheter
Version Model Numberrev 02
Catalog NumberF14-060100-120
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
GS106942265504135 [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 Date2025-05-10

On-Brand Devices [Parafleet SC 014PTA Balloon Dilatation Catheter]

06942265500182rev 02
06942265501646rev 02
06942265501011rev 02
06942265501004rev 02
06942265500991rev 02
06942265500977rev 02
06942265506832rev 02
06942265506627rev 02
06942265506566rev 02
06942265506559rev 02
06942265505750rev 02
06942265505200rev 02
06942265504968rev 02
06942265504296rev 02
06942265504173rev 02
06942265504135rev 02
06942265504074rev 02
06942265503541rev 02
06942265503442rev 02
06942265503411rev 02
06942265503404rev 02
06942265503121rev 02
06942265502797rev 02
06942265502117rev 02

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