Advance Serenity™ 18

GUDID 05391525784250

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 05391525784250
• NIH Device Record Key: 9bc36297-577e-487f-8ec1-1247e8f639b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advance Serenity™ 18
• Version Model Number: SER18-150-35-100
• 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: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 100 Millimeter
• Balloon Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525784250 [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: 2020-04-13
• Device Publish Date: 2020-04-03

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