Identity
- Trade Name
- CS 9300C FDA UDI
- Generic Name
- Cone beam computed tomography system, head/neck FDA UDI
- Device Name
- CS 9300C 230V FDA UDI
- Model / Reference
- CS 9300C FDA UDI
- Description
- CS 9300C 230V FDA UDI
Identifiers
- Catalog Number
- 5319694 FDA UDI
- Primary DI / UDI-DI
- 60889975319698 FDA UDI
- FDA Product Code
- OAS FDA UDI
- GMDN Term
- Cone beam computed tomography system, head/neck FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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: Cone beam computed tomography system, head/neckStationary cephalometric x-ray system, digital
Cs 9300c 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.
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- 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 |
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Manufacturer
- Manufacturer
- Carestream Health, Inc.
Sources (1)
- FDA UDI e07adb9f-205c-49bf-b7d4-dc960dcdbcb1 35 fields · synced Jun 8, 2026