Identity
- Trade Name
- Green RE 400 Speed FDA UDI
- Generic Name
- X-ray film cassette, manual FDA UDI
- Device Name
- USABS CAS US GREEN 400 10X12I. FDA UDI
- Model / Reference
- Green RE 400 Speed 10X12 FDA UDI
- Description
- USABS CAS US GREEN 400 10X12I. FDA UDI
Identifiers
- Catalog Number
- EHYNF FDA UDI
- Primary DI / UDI-DI
- 05414904040157 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
- Length — 10 Inch FDA UDIWidth — 12 Inch FDA UDI
Category: X-ray film cassette, manual
Green RE 400 Speed 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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- Plasdent — PLASDENT CORP. · Class II
- Plasdent — PLASDENT CORP. · Class II
Cleared under the same submission
K023020 also covers:
- AGFA CPB 200 — Agfa Corp.
- AGFA CPB 400 — 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.
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
- Agfa Corp.
Sources (1)
- FDA UDI 93fbe68b-f9b3-42de-9684-849b6a5d0a94 37 fields · synced Jun 1, 2026