← Back to catalogue

CS 8100 Access

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name
CS 8100 Access FDA UDI
Generic Name
Stationary extraoral dental x-ray system, digital FDA UDI
Device Name
CS 8100 ACCESS 110V 230V FDA UDI
Model / Reference
CS 8100 Access FDA UDI
Description
CS 8100 ACCESS 110V 230V FDA UDI

Identifiers

Catalog Number
5303060 FDA UDI
Primary DI / UDI-DI
60889975303062 FDA UDI
FDA Product Code
MUH FDA UDI
GMDN Term
Stationary extraoral 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 extraoral dental x-ray system, digital

CS 8100 Access by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Carestream Health, Inc.

Sources (1)

  • FDA UDI fa808034-eda3-4a45-b096-da7c1ef19c17 34 fields · synced Jun 8, 2026