Advance Serenity™ 18

GUDID 05391525785233

018 Advance Serenity 2x100, 120cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 05391525785233
• NIH Device Record Key: 8275ae07-d2bb-48e9-b661-9461c736d467
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advance Serenity™ 18
• Version Model Number: SER18-120-20-100
• Company DUNS: 985021909
• Company Name: CREAGH MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Balloon Diameter: 2 Millimeter
• Balloon Length: 100 Millimeter
• Catheter Working Length: 120 Centimeter
• Balloon Diameter: 2 Millimeter
• Balloon Length: 100 Millimeter
• Catheter Working Length: 120 Centimeter
• Balloon Diameter: 2 Millimeter
• Balloon Length: 100 Millimeter
• Catheter Working Length: 120 Centimeter
• Balloon Diameter: 2 Millimeter
• Balloon Length: 100 Millimeter
• Catheter Working Length: 120 Centimeter
• Balloon Diameter: 2 Millimeter
• Balloon Length: 100 Millimeter
• Catheter Working Length: 120 Centimeter
• Balloon Diameter: 2 Millimeter
• Balloon Length: 100 Millimeter
• Catheter Working Length: 120 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525785233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180007

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-01
• Device Publish Date: 2022-05-24

On-Brand Devices [Advance Serenity™ 18]

• 05391525784366: SER18-150-40-220
• 05391525784359: SER18-150-40-150
• 05391525784342: SER18-150-40-120
• 05391525784335: SER18-150-40-100
• 05391525784328: SER18-150-40-80
• 05391525784311: SER18-150-40-60
• 05391525784304: SER18-150-40-40
• 05391525784298: SER18-150-40-20
• 05391525784281: SER18-150-35-220
• 05391525784274: SER18-150-35-150
• 05391525784267: SER18-150-35-120
• 05391525784250: SER18-150-35-100
• 05391525784243: SER18-150-35-80
• 05391525784236: SER18-150-35-60
• 05391525784229: SER18-150-35-40
• 05391525784212: SER18-150-35-20
• 05391525784205: SER18-150-30-220
• 05391525784199: SER18-150-30-150
• 05391525784182: SER18-150-30-120
• 05391525784175: SER18-150-30-100
• 05391525784168: SER18-150-30-80
• 05391525784151: SER18-150-30-60
• 05391525784144: SER18-150-30-40
• 05391525784137: SER18-150-30-20
• 05391525784120: SER18-150-25-220
• 05391525784113: SER18-150-25-150
• 05391525784106: SER18-150-25-120
• 05391525784090: SER18-150-25-100
• 05391525784083: SER18-150-25-80
• 05391525784076: SER18-150-25-60
• 05391525784069: SER18-150-25-40
• 05391525784052: SER18-150-25-20
• 05391525784045: SER18-150-20-220
• 05391525784038: SER18-150-20-150
• 05391525784021: SER18-150-20-120
• 05391525784014: SER18-150-20-100
• 05391525784007: SER18-150-20-80
• 05391525783994: SER18-150-20-60
• 05391525783987: SER18-150-20-40
• 05391525783970: SER18-150-20-20
• 05391525785585: 018 Advance Serenity 4x220, 120cm
• 05391525785233: 018 Advance Serenity 2x100, 120cm
• 05391525787022: 018 Advance Serenity 10x80, 90cm
• 05391525787015: 018 Advance Serenity 10x60, 90cm
• 05391525787008: 018 Advance Serenity 10x40, 90cm
• 05391525786995: 018 Advance Serenity 10x20, 90cm
• 05391525786988: 018 Advance Serenity 9x80, 90cm
• 05391525786971: 018 Advance Serenity 9x60, 90cm
• 05391525786964: 018 Advance Serenity 9x40, 90cm
• 05391525786957: 018 Advance Serenity 9x20, 90cm