AED HW5410-BP Tru-Vu Bipolar Hystero-Resectoscope Working Element HW5410-BP

GUDID 00848657074926

An endoscope with a slender rigid inserted portion intended to be used to perform a resection (i.e., the electrosurgical removal of tissue within an organ). It typically consists of an outer sheath, a wide angle telescope, a working guide element and a variety of interchangeable electrosurgical electrodes such as a wire loop, knife, roller ball, ball and coagulating.

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope Resectoscope

• Primary Device ID: 00848657074926
• NIH Device Record Key: 6f9c85c5-057e-4e8e-b2c1-aa298e0d7eff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED HW5410-BP Tru-Vu Bipolar Hystero-Resectoscope Working Element
• Version Model Number: HW5410-BP
• Catalog Number: HW5410-BP
• Company DUNS: 839138955
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md
• Phone: +8182272720
• Email: customerservice@aed.md

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848657074926 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141515

FDA Product Code

• HIH: Hysteroscope (And Accessories)

Sterilization

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

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

[00848657074926]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-06
• Device Publish Date: 2023-08-29

Devices Manufactured by NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

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• 00848657076814 - Curved Metz Scissor, D/A, Rotating, 3mm x 37cm: 2024-07-10 A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp
• 00848657076821 - Large Biopsy Cup Forcep, D/A, 3mm x 37cm: 2024-07-10 A flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastr
• 00848657076920 - ENDOPRO-CAM Master Series: 2024-06-19 Endoscopic Video System
• 00848657076937 - ENDOPRO-MDTK: 2024-06-19 Monostereo 3D Video System Enhancement
• 00848657023108 - AED Power Bank Battery, Rechargeable: 2023-10-20 AED Power Bank Battery, Rechargeable
• 00848657068796 - Retractor: 2023-10-20 A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision t