EMBOTRAP ET309645

GUDID 10886704082859

EMBOTRAP III 6.5 x 45 mm Revascularization Device

NEURAVI LIMITED

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• Primary Device ID: 10886704082859
• NIH Device Record Key: f5f8a2c2-8bc6-4abf-9574-ff3be149c42b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMBOTRAP
• Version Model Number: ET309645
• Catalog Number: ET309645
• Company DUNS: 985010416
• Company Name: NEURAVI 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704082859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211338

FDA Product Code

• NRY: Catheter, Thrombus Retriever

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: 2021-08-13
• Device Publish Date: 2021-08-05

On-Brand Devices [EMBOTRAP]

• 10886704084570: EMBOTRAP III 5 x 37 mm Revascularisation Device
• 10886704082866: EMBOTRAP III 5 x 22 mm Revascularisation Device
• 10886704082859: EMBOTRAP III 6.5 x 45 mm Revascularization Device
• 10886704081326: EMBOTRAP II 5X33 REVASCULARISATION. DEVICE
• 10886704081319: EMBOTRAP II 5X21 REVASCULARISATION DEVICE