Aed

FDA UDI

Class II (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name: AED FDA UDI
Generic Name: Rigid optical cystoscope FDA UDI
Device Name: AED CYSTOSCOPE 4MM X 30 DEGREE ACMI MOUNTS FDA UDI
Model / Reference: M8805B FDA UDI
Description: AED CYSTOSCOPE 4MM X 30 DEGREE ACMI MOUNTS FDA UDI

Identifiers

Primary DI / UDI-DI: 00848657077644 FDA UDI
FDA Product Code: FAJ FDA UDI
GMDN Term: Rigid optical cystoscope FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Rigid optical cystoscope

Aed by National Advanced Endoscopy Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical cystoscope.

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Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
IEC-Innoview GmbH — INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class II
Cystoscope — SOPRO-COMEG GmbH · Class II
Gyrus ACMI — Gyrus Acmi, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: National Advanced Endoscopy Devices, Inc.

Sources (1)

FDA UDI b95c2c8f-923a-432b-ba0b-432fc4d3edec 33 fields · synced May 31, 2026