STANDARD SET 194 Z

GUDID 20607915131313

Kit Contains: CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA090, DIRECT DRIVE LCA 3/BX CTF12, 5x100 Kii Fios ZTHR DP 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: 20607915131313
• NIH Device Record Key: 464aa1f2-35df-49f4-aa37-9c8438a0a0bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STANDARD SET 194 Z
• Version Model Number: GK236
• 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	20607915131313 [Primary]

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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