Primum Guiding Catheter 26102104

GUDID 08718122013915

The Hdrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of intravascualar devices. Also available with two (2) Side Holes in the tip section.

PendraCare International B.V.

Vascular guide-catheter, single-use

• Primary Device ID: 08718122013915
• NIH Device Record Key: 5cb5f3fd-1fcf-473e-8694-c0dcc4d66bd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primum Guiding Catheter
• Version Model Number: 6F Primum JL3.5
• Catalog Number: 26102104
• Company DUNS: 413008652
• Company Name: PendraCare International B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• 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	08718122013915 [Primary]
GS1	38718122013916 [Package]; Package: box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250972

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: 2026-02-10
• Device Publish Date: 2026-02-02

On-Brand Devices [Primum Guiding Catheter]

• 38718122028897: The Hydrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of i
• 38718122013985: The Hdrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of in
• 08718122013915: The Hdrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of in