AED HS55-35 Operative Hysteroscope, 5.5mm x 3.5mm HS55-35

GUDID 00848657075978

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). This device is commonly used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia).

NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.

Rigid optical hysteroscope

• Primary Device ID: 00848657075978
• NIH Device Record Key: 21151566-72a1-43bc-9106-6dbca5675a43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AED HS55-35 Operative Hysteroscope, 5.5mm x 3.5mm
• Version Model Number: HS55-35
• Catalog Number: HS55-35
• 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: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md
• Phone: +1(818) 227-2720
• Email: customerservice@aed.md

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848657075978 [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

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

[00848657075978]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-26
• Device Publish Date: 2023-05-18

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