Cs 8100sc 3d

FDA UDI

Class II (US FDA UDI)

by Carestream Health, Inc.

Identity

Trade Name: CS 8100SC 3D FDA UDI
Generic Name: Stationary cephalometric x-ray system, digital FDA UDI
Device Name: CS 8100SC 3D FDA UDI
Model / Reference: CS 8100SC 3D FDA UDI
Description: CS 8100SC 3D FDA UDI

Identifiers

Catalog Number: 5500111 FDA UDI
Primary DI / UDI-DI: 60889975500119 FDA UDI
FDA Product Code: MUH FDA UDI
OAS FDA UDI
GMDN Term: Stationary cephalometric x-ray system, digital FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.1800 FDA UDI
892.1750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cone beam computed tomography system, head/neck Stationary cephalometric x-ray system, digital

Cs 8100sc 3d by Carestream Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Stationary cephalometric x-ray system, digital.

CS 9300C — Carestream Dental LLC · Class II
Midmark Vantage Cephalometric Sensor — Midmark Corporation · Class II
Ceph attachment with sensor — Midmark Corporation · Class II
Midmark Vantage Cephalometric Sensor — Midmark Corporation · Class II
CEPHALOSTAT — Carestream Dental LLC · Class II
CS 9300C — Carestream Dental LLC · Class II
Midmark Vantage Cephalometric Sensor — Midmark Corporation · Class II
Ceph Attachmetnt without sensor — Midmark Corporation · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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

Manufacturer

Manufacturer: Carestream Health, Inc.

Sources (1)

FDA UDI 6d0a7be8-6e9c-42a0-9456-7b25215710fb 35 fields · synced Jun 8, 2026