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CS 3D Imaging Software

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
CS 3D Imaging Software FDA UDI
Generic Name
General-purpose dental x-ray system application software FDA UDI
Device Name
CS 3D IMAGING FDA UDI
Model / Reference
CS 3D Imaging Software FDA UDI
Description
CS 3D IMAGING FDA UDI

Identifiers

Catalog Number
5319587 FDA UDI
Primary DI / UDI-DI
60889975319582 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
General-purpose dental x-ray system application software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General-purpose dental x-ray system application software

CS 3D Imaging Software by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General-purpose dental x-ray system application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Carestream Health, Inc.

Sources (1)

  • FDA UDI e6a5ef4a-15b2-4f34-b350-566856ebca56 34 fields · synced Jun 8, 2026