AED HS5400-BP Bipolar Hystero-Resectoscope Set HS5400-BP

GUDID 00848657074919

An endoscope with a slender rigid inserted portion, which 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

• Primary Device ID: 00848657074919
• NIH Device Record Key: 1b657650-e00c-4524-bf9c-020a13f6bd79
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED HS5400-BP Bipolar Hystero-Resectoscope Set
• Version Model Number: HS5400-BP
• Catalog Number: HS5400-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	00848657074919 [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

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

Moist Heat or Steam Sterilization

[00848657074919]

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

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• 00848657077187 - AED: 2025-09-02 AED Laparoscope, 10mm X 43cm, 0 Degree
• 00848657077194 - AED: 2025-09-02 AED SINUS SIDE PUNCH LEFT #501.28
• 00848657077200 - AED: 2025-09-02 AED Endoscope - 5mm x 0 degree, 30cm
• 00848657077217 - AED: 2025-09-02 AED Laparoscope, 5mm X 30cm, 30 Degree
• 00848657077224 - AED: 2025-09-02 OLYMPUS MOUNT ARTHROSCOPE 4MM X 30 DEGREES, 160MM