Micro Rx RX1325

GUDID 08718481740354

The Micro Rx is a guide wire support catheter with hydrophilic coating intended to support a guide wire during access of coronary and/ or peripheral vasculature. The Micro Rx consist of a distal shaft connected to a push rod with a proximal end stop on the proximal end and a tip on the distal end of the catheter. On the push rod shaft depth markings are applied to indicate that the distal tip of the catheter is at the level of the distal tip of the guiding catheter (95 and 105 cm). Additional distal shaft transition markings are applied to indicate the distal shaft transition is reaching the distal end of the guiding catheter (110 and 120 cm). As aid in positioning the distal tip is radiopaque to make the tip visible with fluoroscopy. The distal part of the shaft is fitted with a hydrophilic coating. The inner lumen of the catheter is coated with MDX coating.

IMDS Operations B.V.

Vascular guide-catheter, single-use

• Primary Device ID: 08718481740354
• NIH Device Record Key: 9b6a777d-3bca-46b9-b51c-0d661cee89f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Micro Rx
• Version Model Number: RX135
• Catalog Number: RX1325
• 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	08718481740354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223728

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: 2023-12-27
• Device Publish Date: 2023-12-19

Devices Manufactured by IMDS Operations B.V.

• 08718481740354 - Micro Rx: 2023-12-27The Micro Rx is a guide wire support catheter with hydrophilic coating intended to support a guide wire during access of coronary and/ or peripheral vasculature. The Micro Rx consist of a distal shaft connected to a push rod with a proximal end stop on the proximal end and a tip on the distal end of the catheter. On the push rod shaft depth markings are applied to indicate that the distal tip of the catheter is at the level of the distal tip of the guiding catheter (95 and 105 cm). Additional distal shaft transition markings are applied to indicate the distal shaft transition is reaching the distal end of the guiding catheter (110 and 120 cm). As aid in positioning the distal tip is radiopaque to make the tip visible with fluoroscopy. The distal part of the shaft is fitted with a hydrophilic coating. The inner lumen of the catheter is coated with MDX coating.
• 08718481740354 - Micro Rx: 2023-12-27 The Micro Rx is a guide wire support catheter with hydrophilic coating intended to support a guide wire during access of coronar
• 08718481740231 - NHancer Rx: 2022-09-09 The NHancer™Rx is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The NHancer™Rx is a 0
• 08718481740262 - TrapIT: 2022-09-09 The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen w
• 08718481740279 - TrapIT: 2022-09-09 The TrapIt Trapping Balloon Catheters have an integrated shaft system and a balloon near the distal tip. The shaft has a lumen w
• 08718481740309 - ReCross: 2022-09-09 The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014” Ov