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Cg797

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
CG797 FDA UDI
Generic Name
Stationary intraoral dental x-ray system, digital FDA UDI
Device Name
SIZE A COLLIMAT. FOR I/O XRAY UNITS FDA UDI
Model / Reference
CG797 FDA UDI
Description
SIZE A COLLIMAT. FOR I/O XRAY UNITS FDA UDI

Identifiers

Catalog Number
5154232 FDA UDI
Primary DI / UDI-DI
60889975154237 FDA UDI
FDA Product Code
EHD FDA UDI
GMDN Term
Stationary intraoral dental x-ray system, digital FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.1800 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Stationary intraoral dental x-ray system, digital

Cg797 by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary intraoral dental x-ray system, digital.

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 41940351-ecb6-4e6d-9ef2-d9f9c03682e6 34 fields · synced Jun 8, 2026