Monopolar Hook

GUDID 07290017376080

HUMAN XTENSIONS LTD

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• Primary Device ID: 07290017376080
• NIH Device Record Key: adc7cc3b-f572-487f-b83a-47bd35a257ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monopolar Hook
• Version Model Number: 20-30-044-01
• Company DUNS: 600165869
• Company Name: HUMAN XTENSIONS LTD
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017376080 [Primary]
GS1	17290017376087 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203603

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

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: 2021-06-14
• Device Publish Date: 2021-06-06

Devices Manufactured by HUMAN XTENSIONS LTD

• 17290017376179 - Monopolar Scissors: 2023-06-15
• 17290017376193 - Self-Righting Needle Holder: 2023-06-15
• 07290017376080 - Monopolar Hook: 2021-06-14
• 07290017376080 - Monopolar Hook: 2021-06-14
• 17290017376001 - HandX: 2018-10-08 The HandX is intended to assist in the accurate control of HX laparoscopic Instruments including needle holder and grasper, for
• 17290017376018 - HandX Fenestrated Grasper 5mm: 2018-10-08
• 17290017376025 - HandX Needle Holder 5mm: 2018-10-08
• 17290017376032 - HandX Disposables: 2018-10-08 HandX Disposables include 1 Arc&Pads pouch and 1 DC Power Cable