KE011 SET URGENCIAS

GUDID 20607915130712

Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF73, 12x100 Kii Fios ZTHR 6/BX CTB73, 12x100 Kii SH BLD ZTHR 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX

APPLIED MEDICAL RESOURCES CORPORATION

Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag Tissue extraction bag

• Primary Device ID: 20607915130712
• NIH Device Record Key: ee06736e-2793-4f23-9891-07d1df59057a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KE011 SET URGENCIAS
• Version Model Number: GK222
• 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: true
• 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: true
• 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
• 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
• 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
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com
• Phone: 1.949.713.8300
• Email: contact@appliedmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	20607915130712 [Primary]

FDA Product Code

• FHF: System, Evacuator, Fluid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-01-09
• Device Publish Date: 2015-10-09

Devices Manufactured by APPLIED MEDICAL RESOURCES CORPORATION

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• 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