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Aed

FDA UDI

Class II (US FDA UDI)

by National Advanced Endoscopy Devices, Inc.

Identity

Trade Name
AED FDA UDI
Generic Name
Rigid optical sinoscope FDA UDI
Device Name
AED Sinuscope 2.7mm x 70 degree, 170mm FDA UDI
Model / Reference
8827C FDA UDI
Description
AED Sinuscope 2.7mm x 70 degree, 170mm FDA UDI

Identifiers

Primary DI / UDI-DI
00848657085854 FDA UDI
510(k) Number
K170285 FDA UDI
FDA Product Code
EOB FDA UDI
GMDN Term
Rigid optical sinoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4760 FDA UDI
Commercial Distribution
Not 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
Hydrogen Peroxide FDA UDI

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

Cleared under the same submission

K170285 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 1fb2f564-8daf-4b6e-9054-eac5638472e9 35 fields · synced Jun 1, 2026