Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter

GUDID 05391525787497

018 Advance Serenity 6x220, 135cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic
Primary Device ID05391525787497
NIH Device Record Keye9f412b2-2294-4232-89c4-588241ae31bd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdvance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter
Version Model NumberSER18-135-60-220
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 Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter
Balloon Diameter6 Millimeter
Balloon Length220 Millimeter
Catheter Working Length135 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105391525787497 [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 Date2025-03-24
Device Publish Date2025-03-14

On-Brand Devices [Advance Serenity® 18 Hydrophilic PTA Balloon Dilatation Catheter]

05391525787503018 Advance Serenity 7x220, 135cm
05391525787497018 Advance Serenity 6x220, 135cm
05391525787480018 Advance Serenity 5x220, 135cm

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

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