Advance Serenity™ 18

GUDID 05391525784274

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic
Primary Device ID05391525784274
NIH Device Record Key35d99e11-7281-455f-a332-b23456b42cd0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvance Serenity™ 18
Version Model NumberSER18-150-35-150
Company DUNS985021909
Company NameCREAGH MEDICAL LIMITED
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Balloon Diameter3.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105391525784274 [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 Date2020-04-13
Device Publish Date2020-04-03

On-Brand Devices [Advance Serenity™ 18]

05391525784366SER18-150-40-220
05391525784359SER18-150-40-150
05391525784342SER18-150-40-120
05391525784335SER18-150-40-100
05391525784328SER18-150-40-80
05391525784311SER18-150-40-60
05391525784304SER18-150-40-40
05391525784298SER18-150-40-20
05391525784281SER18-150-35-220
05391525784274SER18-150-35-150
05391525784267SER18-150-35-120
05391525784250SER18-150-35-100
05391525784243SER18-150-35-80
05391525784236SER18-150-35-60
05391525784229SER18-150-35-40
05391525784212SER18-150-35-20
05391525784205SER18-150-30-220
05391525784199SER18-150-30-150
05391525784182SER18-150-30-120
05391525784175SER18-150-30-100
05391525784168SER18-150-30-80
05391525784151SER18-150-30-60
05391525784144SER18-150-30-40
05391525784137SER18-150-30-20
05391525784120SER18-150-25-220
05391525784113SER18-150-25-150
05391525784106SER18-150-25-120
05391525784090SER18-150-25-100
05391525784083SER18-150-25-80
05391525784076SER18-150-25-60
05391525784069SER18-150-25-40
05391525784052SER18-150-25-20
05391525784045SER18-150-20-220
05391525784038SER18-150-20-150
05391525784021SER18-150-20-120
05391525784014SER18-150-20-100
05391525784007SER18-150-20-80
05391525783994SER18-150-20-60
05391525783987SER18-150-20-40
05391525783970SER18-150-20-20
05391525785585018 Advance Serenity 4x220, 120cm
05391525785233018 Advance Serenity 2x100, 120cm
05391525787022018 Advance Serenity 10x80, 90cm
05391525787015018 Advance Serenity 10x60, 90cm
05391525787008018 Advance Serenity 10x40, 90cm
05391525786995018 Advance Serenity 10x20, 90cm
05391525786988018 Advance Serenity 9x80, 90cm
05391525786971018 Advance Serenity 9x60, 90cm
05391525786964018 Advance Serenity 9x40, 90cm
05391525786957018 Advance Serenity 9x20, 90cm

Trademark Results [Advance Serenity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ADVANCE SERENITY
ADVANCE SERENITY
88610774 not registered Live/Pending
Cook Medical Technologies LLC
2019-09-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.