Tersus -14 BTK

GUDID 05391518031026

Tersus-14 BTK4020S 4mm x 20mm x 120cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 05391518031026
• NIH Device Record Key: 1debdb60-53d2-477d-8830-d5b87526e5e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tersus -14 BTK
• Version Model Number: BTK4020S
• 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

• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter
• Length: 20 Millimeter
• Outer Diameter: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391518031026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102645

FDA Product Code

• LIT: Catheter, Angioplasty, Peripheral, Transluminal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Tersus -14 BTK]

• 05391518031378: Tersus-14 BTK40220L 4mm x 220mm x 150cm
• 05391518031361: Tersus-14 BTK40150L 4mm x 150mm x 150cm
• 05391518031354: Tersus-14 BTK40100L 4mm x 100mm x 150cm
• 05391518031347: Tersus-14 BTK4080L 4mm x 80mm x 150cm
• 05391518031330: Tersus-14 BTK4060L 4mm x 60mm x 150cm
• 05391518031323: Tersus-14 BTK4020L 4mm x 20mm x 150cm
• 05391518031316: Tersus-14 BTK35220L 3.5mm x 220mm x 150cm
• 05391518031309: Tersus-14 BTK35150L 3.5mm x 150mm x 150cm
• 05391518031293: Tersus-14 BTK35100L 3.5mm x 100mm x 150cm
• 05391518031286: Tersus-14 BTK3580L 3.5mm x 80mm x 150cm
• 05391518031279: Tersus-14 BTK3560L 3.5mm x 60mm x 150cm
• 05391518031262: Tersus-14 BTK3520L 3.5mm x 20mm x 150cm
• 05391518031255: Tersus-14 BTK30220L 3mm x 220mm x 150cm
• 05391518031248: Tersus-14 BTK30150L 3mm x 150mm x 150cm
• 05391518031231: Tersus-14 BTK30100L 3mm x 100mm x 150cm
• 05391518031224: Tersus-14 BTK3080L 3mm x 80mm x 150cm
• 05391518031217: Tersus-14 BTK3060L 3mm x 60mm x 150cm
• 05391518031200: Tersus-14 BTK3020L 3mm x 20mm x 150cm
• 05391518031194: Tersus-14 BTK25220L 2.5mm x 220mm x 150cm
• 05391518031187: Tersus-14 BTK25150L 2.5mm x 150mm x 150cm
• 05391518031170: Tersus-14 BTK25100L 2.5mm x 100mm x 150cm
• 05391518031163: Tersus-14 BTK2580L 2.5mm x 80mm x 150cm
• 05391518031156: Tersus-14 BTK2560L 2.5mm x 60mm x 150cm
• 05391518031149: Tersus-14 BTK2520L 2.5mm x 20mm x 150cm
• 05391518031132: Tersus-14 BTK20220L 2mm x 220mm x 150cm
• 05391518031125: Tersus-14 BTK20150L 2mm x 150mm x 150cm
• 05391518031118: Tersus-14 BTK20100L 2mm x 100mm x 150cm
• 05391518031101: Tersus-14 BTK2080L 2mm x 80mm x 150cm
• 05391518031095: Tersus-14 BTK2060L 2mm x 60mm x 150cm
• 05391518031088: Tersus-14 BTK2020L 2mm x 20mm x 150cm
• 05391518031071: Tersus-14 BTK40220S 4mm x 220mm x 120cm
• 05391518031064: Tersus-14 BTK40150S 4mm x 150mm x 120cm
• 05391518031057: Tersus-14 BTK40100S 4mm x 100mm x 120cm
• 05391518031040: Tersus-14 BTK4080S 4mm x 80mm x 120cm
• 05391518031033: Tersus-14 BTK4060S 4mm x 60mm x 120cm
• 05391518031026: Tersus-14 BTK4020S 4mm x 20mm x 120cm
• 05391518031019: Tersus-14 BTK35220S 3.5mm x 220mm x 120cm
• 05391518031002: Tersus-14 BTK35150S 3.5mm x 150mm x 120cm
• 05391518030999: Tersus-14 BTK35100S 3.5mm x 100mm x 120cm
• 05391518030982: Tersus-14 BTK3580S 3.5mm x 80mm x 120cm
• 05391518030975: Tersus-14 BTK3560S 3.5mm x 60mm x 120cm
• 05391518030968: Tersus-14 BTK3520S 3.5mm x 20mm x 120cm
• 05391518030951: Tersus-14 BTK30220S 3mm x 220mm x 120cm
• 05391518030944: Tersus-14 BTK30150S 3mm x 150mm x 120cm
• 05391518030937: Tersus-14 BTK30100S 3mm x 100mm x 120cm
• 05391518030920: Tersus-14 BTK3080S 3mm x 80mm x 120cm
• 05391518030913: Tersus-14 BTK3060S 3mm x 60mm x 120cm
• 05391518030906: Tersus-14 BTK3020S 3mm x 20mm x 120cm
• 05391518030890: Tersus-14 BTK25220S 2.5mm x 220mm x 120cm
• 05391518030883: Tersus-14 BTK25150S 2.5mm x 150mm x 120cm