Identity
- Trade Name
- CR MD4.0T GENERAL CASSETTE FDA UDI
- Generic Name
- Digital imaging cassette FDA UDI
- Device Name
- CR MD4.0T CASSETTE 35X35 CM FDA UDI
- Model / Reference
- CR MD4.0T GENERAL CASSETTE 35X35 FDA UDI
- Description
- CR MD4.0T CASSETTE 35X35 CM FDA UDI
Identifiers
- Catalog Number
- 5TRL8 FDA UDI
- Primary DI / UDI-DI
- 05414904111390 FDA UDI
- 510(k) Number
- K062223 FDA UDI
- FDA Product Code
- MQB FDA UDI
- GMDN Term
- Digital imaging cassette FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1680 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 35 Centimeter FDA UDILength — 35 Centimeter FDA UDI
Category: Digital imaging cassette
Cr Md4.0t General Cassette by Agfa Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K062223 also covers:
- CR MD4.0T FLFS CASSETTE — Agfa Corp.
- CR MD4.0T FLFS SET — Agfa Corp.
- CR MD4.0T GENERAL CASSETTE — Agfa Corp.
- CR MD4.0T GENERAL CASSETTE — Agfa Corp.
- CR MD4.0T GENERAL CASSETTE — Agfa Corp.
- CR MD4.0T GENERAL CASSETTE — Agfa Corp.
- CR MD4.0T GENERAL SET — Agfa Corp.
- CR MD4.0T GENERAL SET — Agfa Corp.
- CR MD4.0T GENERAL SET — Agfa Corp.
- CR MD4.0T GENERAL SET — Agfa Corp.
- CR MD4.0T GENERAL SET — Agfa Corp.
- CR MD4.0T PLATE — 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 55e028fb-a500-4f6c-be76-a8380dd4604d 37 fields · synced May 30, 2026