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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 laparoscope FDA UDI
Device Name
Tru Vu Mini Operative Laparoscope, 3.5mm x 30cm, 5FR Channel FDA UDI
Model / Reference
ML3500 FDA UDI
Description
Tru Vu Mini Operative Laparoscope, 3.5mm x 30cm, 5FR Channel FDA UDI

Identifiers

Primary DI / UDI-DI
00848657085755 FDA UDI
510(k) Number
K993688 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Rigid optical laparoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

K993688 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 4da9aece-2cbc-49da-a77c-44e6a3204c40 35 fields · synced May 29, 2026