Identity
- Trade Name
- AGFA CPB 400 FDA UDI
- Generic Name
- X-ray film cassette, manual FDA UDI
- Device Name
- AGFA CAS EU+CPB 400 13X18 FDA UDI
- Model / Reference
- AGFA CPB 400 13X18 FDA UDI
- Description
- AGFA CAS EU+CPB 400 13X18 FDA UDI
Identifiers
- Catalog Number
- 347NN FDA UDI
- Primary DI / UDI-DI
- 05414904037249 FDA UDI
- 510(k) Number
- K023020 FDA UDI
- FDA Product Code
- IXA FDA UDI
- GMDN Term
- X-ray film cassette, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1850 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 18 Centimeter FDA UDILength — 13 Centimeter FDA UDI
Category: X-ray film cassette, manual
Agfa Cpb 400 by Agfa Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as X-ray film cassette, manual.
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- Universal Cassette 35cmx43cm(IP 35cmx43cm)Kit — DIGIRAY Corp. · Class II
- Plasdent — PLASDENT CORP. · Class I
- Plasdent — PLASDENT CORP. · Class II
- Plasdent — PLASDENT CORP. · Class II
Cleared under the same submission
K023020 also covers:
- AGFA CPB 200 — Agfa Corp.
- CURIX OPTHOS H — Agfa Corp.
- CURIX ORTHO FAST — Agfa Corp.
- CURIX ORTHO FAST — Agfa Corp.
- CURIX ORTHO FAST — Agfa Corp.
- CURIX ORTHO FAST — Agfa Corp.
- CURIX ORTHO FAST — Agfa Corp.
- CURIX ORTHO FAST — Agfa Corp.
- CURIX ORTHO FAST — Agfa Corp.
- CURIX ORTHO FAST — Agfa Corp.
- CURIX ORTHO FAST — Agfa Corp.
- CURIX ORTHO FAST — Agfa Corp.
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
- Agfa Corp.
Sources (1)
- FDA UDI 5cf29156-c5e8-43b2-90f3-93a88b2aa6be 37 fields · synced May 30, 2026