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X-OMAT 2 Dental Duplicating

FDA UDI

Class I (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
X-OMAT 2 Dental Duplicating FDA UDI
Generic Name
Medical x-ray film, non-screen FDA UDI
Device Name
X-OMAT 2 Dental DUP 50SH 8x10in film FDA UDI
Model / Reference
X-OMAT 2 Dental Duplicating FDA UDI
Description
X-OMAT 2 Dental DUP 50SH 8x10in film FDA UDI

Identifiers

Catalog Number
1753185 FDA UDI
Primary DI / UDI-DI
40889971753188 FDA UDI
FDA Product Code
IWZ FDA UDI
GMDN Term
Medical x-ray film, non-screen FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1840 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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: Medical x-ray film, non-screen

X-OMAT 2 Dental Duplicating by Carestream Health, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical x-ray film, non-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 72a10871-d19d-4a37-8e6f-336c13426bc6 35 fields · synced Jun 6, 2026