Aed

FDA UDI

Class II (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name: AED FDA UDI
Generic Name: Urethrotome FDA UDI
Device Name: AED Dittel Bougies curved without channel 8 CH FDA UDI
Model / Reference: 32-4429 FDA UDI
Description: AED Dittel Bougies curved without channel 8 CH FDA UDI

Identifiers

Primary DI / UDI-DI: 00848657021081 FDA UDI
FDA Product Code: EZO FDA UDI
GMDN Term: Urethrotome FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4770 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

Yes

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: Urethrotome

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

Similar devices

Also classified as Urethrotome.

Urethrotomy knife — SOPRO-COMEG GmbH · Class II
Trokamed — TROKAMED GmbH · Class II
Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class II
Greenwald Surgical Company, Inc. — GRACE MANUFACTURING INC · Class II
RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
Urethrotomy knife — SOPRO-COMEG GmbH · Class II
Urethrotomy knife — SOPRO-COMEG GmbH · Class II
Greenwald Surgical Company, Inc. — GRACE MANUFACTURING 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 e17bdc80-f79d-409e-bf36-b70285609ba1 33 fields · synced May 30, 2026