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Gendex GXC-300™ intraoral camera

FDA UDI

Class I (US FDA UDI)

by Gendex Corp.

Identity

Trade Name
Gendex GXC-300™ intraoral camera FDA UDI
Generic Name
Multi-purpose digital medical camera FDA UDI
Device Name
Digital intraoral camera FDA UDI
Model / Reference
0.822.4331 FDA UDI
Description
Digital intraoral camera FDA UDI

Identifiers

Catalog Number
GXC300 FDA UDI
Primary DI / UDI-DI
EKAV082243310 FDA UDI
510(k) Number
K040691 FDA UDI
FDA Product Code
EIA FDA UDI
GMDN Term
Multi-purpose digital medical camera FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multi-purpose digital medical camera

Gendex GXC-300™ intraoral camera by Gendex Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multi-purpose digital medical camera.

Cleared under the same submission

K040691 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gendex Corp.

Sources (1)

  • FDA UDI b373d4bf-9daf-4897-95dd-0c13790d0340 37 fields · synced May 30, 2026