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Aed

FDA UDI

Class I (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name
AED FDA UDI
Generic Name
ENT surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Optical/Sinus Forceps FDA UDI
Model / Reference
22-2701 FDA UDI
Description
Optical/Sinus Forceps FDA UDI

Identifiers

Primary DI / UDI-DI
00848657006453 FDA UDI
510(k) Number
K993689 FDA UDI
FDA Product Code
KAE FDA UDI
GMDN Term
ENT surgical procedure kit, non-medicated, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: ENT surgical procedure kit, non-medicated, reusable

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

Similar devices

Also classified as ENT surgical procedure kit, non-medicated, reusable.

Cleared under the same submission

K993689 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
National Advanced Endoscopy Devices, Inc.

Sources (1)

  • FDA UDI bfd6bd03-3dd3-41ed-a50e-7150e27873e0 34 fields · synced May 31, 2026