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Imaging Plate

FDA UDI

Class I (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
Imaging Plate FDA UDI
Generic Name
Digital imaging storage phosphor screen FDA UDI
Device Name
(2) SZ 1 DENTAL CR I/O IMAG PLATES FDA UDI
Model / Reference
Imaging Plate FDA UDI
Description
(2) SZ 1 DENTAL CR I/O IMAG PLATES FDA UDI

Identifiers

Catalog Number
8406845 FDA UDI
Primary DI / UDI-DI
40889978406841 FDA UDI
FDA Product Code
EAM FDA UDI
GMDN Term
Digital imaging storage phosphor screen FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1960 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Digital imaging storage phosphor screen

Imaging Plate by Carestream Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Digital imaging storage phosphor screen.

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 bcf28808-ab3e-4c28-9983-54d9cd13ac9f 35 fields · synced Jun 8, 2026