Sentry IVC Filter NM60-16-28

GUDID 05391529380076

The Sentry IVC Filter is indicated for the prevention of recurrent Pulmonary Embolism via percutaneous placement in the inferior vena cava in patients at transient risk of PE, in the following situations: • Pulmonary thromboembolism when anticoagulants are contraindicated. • Failure of anticoagulant therapy in thromboembolic diseases. • Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced.

NOVATE MEDICAL LIMITED

Vena cava filter, temporary/permanent

• Primary Device ID: 05391529380076
• NIH Device Record Key: 41f8a47f-e5d1-4f41-a95a-f27d075a4e8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentry IVC Filter
• Version Model Number: 146155-01
• Catalog Number: NM60-16-28
• Company DUNS: 896415242
• Company Name: NOVATE MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: +35391750030
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391529380069 [Primary]
GS1	05391529380076 [Package]; Contains: 05391529380069; Package: [5 Units]; In Commercial Distribution

FDA Product Code

• DTK: Filter, Intravascular, Cardiovascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-01
• Device Publish Date: 2018-09-27