IRR-023-10F

GUDID 00607915118235

Irrigation Catheter

APPLIED MEDICAL RESOURCES CORPORATION

Irrigation catheter, single-lumen Irrigation catheter, single-lumen Irrigation catheter, single-lumen

• Primary Device ID: 00607915118235
• NIH Device Record Key: 92045afd-cdb2-44b2-9f98-8e7d4c08a474
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRR-023-10F
• Version Model Number: IRR-023-10F
• Company DUNS: 187129135
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• 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

Customer Support Contacts

• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com

Device Dimensions

• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Catheter Gauge: 10 French
• Length: 23 Centimeter
• Catheter Gauge: 10 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00607915118235 [Primary]

FDA Product Code

• GCA: Catheter, Biliary, Surgical

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: 2018-03-29
• Device Publish Date: 2016-08-22

Devices Manufactured by APPLIED MEDICAL RESOURCES CORPORATION

• 10607915145528 - Inzii Ripstop Redeployable Retrieval System: 2024-03-27 Redeployable tissue retrieval system with Ripstop nylon bag.
• 00607915146498 - Suction Irrigation System: 2024-02-09 Probe and Valve with dual bag tubing.
• 00607915146504 - Suction Irrigation System: 2024-02-09 Valve with dual bag tubing.
• 10607915140790 - Voyant Maryland Fusion Device with Single-Step Activation: 2023-04-04 Electrosurgical Sealer and Divider handpiece
• 00607915140809 - Voyant Maryland Fusion Device with Single-Step Activation: 2023-04-04 Voyant Maryland Fusion Device with Single-Step Activation
• 10607915140813 - Voyant Maryland Fusion Device with Single-Step Activation: 2023-04-04 Electrosurgical Sealer and Divider handpiece
• 10607915145313 - GelPOINT V-Path: 2023-03-27 Transvaginal Access Platform with Insufflation Stabilization System
• 10607915145320 - GelPOINT V-Path: 2023-03-27 Transvaginal Access Platform with Insufflation Stabilization System