GALBLAAS Z-THREAD 2

GUDID 20607915130613

Kit Contains: CTF12, 5x100 Kii Fios ZTHR DP 10/BX CTF73, 12x100 Kii Fios ZTHR 6/BX CTS22, 12x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX

APPLIED MEDICAL RESOURCES CORPORATION

Spring-loaded pneumoperitoneum needle, single-use

• Primary Device ID: 20607915130613
• NIH Device Record Key: d7465e69-cf76-4210-acb3-91c3f07ba4e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GALBLAAS Z-THREAD 2
• Version Model Number: GK227
• 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	20607915130613 [Primary]

FDA Product Code

• HET: Laparoscope, Gynecologic (And Accessories)

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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• 00607915149024 - Inzii Ripstop Retrieval System: 2026-01-26
• 00607915140700 - Alexis® Orthopaedic Protector: 2025-04-16 X-S/M Flexible Alexis Orthopaedic Protector
• 00607915114688 - Threaded Cannula and Seal: 2024-12-16 Laparoscopic Trocar Sleeve
• 10607915140325 - Alexis® O Wound Protector-Retractor: 2024-09-04 Wound Retractor and Protector
• 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.