Sublime™ 014 Rx PTA Balloon Dilatation Catheter

GUDID 05391525783857

014 Radial Catheter 3.5mm x 60mm x 250cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 05391525783857
• NIH Device Record Key: e69b6854-1174-4cd2-aa0c-f363c6ffcfa5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sublime™ 014 Rx PTA Balloon Dilatation Catheter
• Version Model Number: SRA-DC14-35060
• 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: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0
• Balloon Diameter: 3.5 Millimeter
• Balloon Length: 60 Millimeter
• Catheter Length: 250 Centimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391525783857 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200700

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: 2021-03-17
• Device Publish Date: 2021-03-09

On-Brand Devices [Sublime™ 014 Rx PTA Balloon Dilatation Catheter]

• 05391525783789: 014 Radial Catheter 3mm x 60mm x 250cm
• 05391525783772: 014 Radial Catheter 3mm x 40mm x 250cm
• 05391525783765: 014 Radial Catheter 3mm x 20mm x 250cm
• 05391525783758: 014 Radial Catheter 2.5mm x 220mm x 250cm
• 05391525783741: 014 Radial Catheter 2.5mm x 150mm x 250cm
• 05391525783734: 014 Radial Catheter 2.5mm x 100mm x 250cm
• 05391525783727: 014 Radial Catheter 2.5mm x 80mm x 250cm
• 05391525783710: 014 Radial Catheter 2.5mm x 60mm x 250cm
• 05391525783703: 014 Radial Catheter 2.5mm x 40mm x 250cm
• 05391525783697: 014 Radial Catheter 2.5mm x 20mm x 250cm
• 05391525783680: 014 Radial Catheter 2mm x 220mm x 250cm
• 05391525783673: 014 Radial Catheter 2mm x 150mm x 250cm
• 05391525783666: 014 Radial Catheter 2mm x 100mm x 250cm
• 05391525783659: 014 Radial Catheter 2mm x 80mm x 250cm
• 05391525783642: 014 Radial Catheter 2mm x 60mm x 250cm
• 05391525783635: 014 Radial Catheter 2mm x 40mm x 250cm
• 05391525783628: 014 Radial Catheter 2mm x 20mm x 250cm
• 05391525783963: 014 Radial Catheter 4mm x 220mm x 250cm
• 05391525783956: 014 Radial Catheter 4mm x 150mm x 250cm
• 05391525783949: 014 Radial Catheter 4mm x 100mm x 250cm
• 05391525783932: 014 Radial Catheter 4mm x 80mm x 250cm
• 05391525783925: 014 Radial Catheter 4mm x 60mm x 250cm
• 05391525783918: 014 Radial Catheter 4mm x 40mm x 250cm
• 05391525783901: 014 Radial Catheter 4mm x 20mm x 250cm
• 05391525783895: 014 Radial Catheter 3.5mm x 220mm x 250cm
• 05391525783888: 014 Radial Catheter 3.5mm x 150mm x 250cm
• 05391525783871: 014 Radial Catheter 3.5mm x 100mm x 250cm
• 05391525783864: 014 Radial Catheter 3.5mm x 80mm x 250cm
• 05391525783857: 014 Radial Catheter 3.5mm x 60mm x 250cm
• 05391525783840: 014 Radial Catheter 3.5mm x 40mm x 250cm
• 05391525783833: 014 Radial Catheter 3.5mm x 20mm x 250cm
• 05391525783826: 014 Radial Catheter 3mm x 220mm x 250cm
• 05391525783819: 014 Radial Catheter 3mm x 150mm x 250cm
• 05391525783802: 014 Radial Catheter 3mm x 100mm x 250cm
• 05391525783796: 014 Radial Catheter 3mm x 80mm x 250cm