Tersus-14 BTK

GUDID 05391518030784

Tersus-14 BTK2020S 2mm x 20mm x 120cm

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic

• Primary Device ID: 05391518030784
• NIH Device Record Key: d0246ba6-d779-4b1e-8997-dbd5baab5965
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tersus-14 BTK
• Version Model Number: BTK2020S
• 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: 2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391518030784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102645

FDA Product Code

• DQY: Catheter, Percutaneous

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

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