TrapIT TRP9015

GUDID 08718481740262

The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen which is used for inflation of the balloon with contrast medium. As aid in positioning the balloon in a guide catheter a tactile feedback stop is integrated in the shaft. The shaft of the 100 cm compatible TrapIt has a shaft depth marking that aid in gauging balloon catheter position relative to the guiding catheter tip when used in 90 cm guide catheters.

IMDS Operations B.V.

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• Primary Device ID: 08718481740262
• NIH Device Record Key: fce0966a-7eda-4a80-a306-96b9047559bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TrapIT
• Version Model Number: TRP9015
• Catalog Number: TRP9015
• Company DUNS: 489997508
• Company Name: IMDS Operations B.V.
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	08718481740262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191229

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2022-09-09
• Device Publish Date: 2022-09-01

On-Brand Devices [TrapIT]

• 08718481740279: The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the dis
• 08718481740262: The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the dis