FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CR MD4.0 GENERAL PLATE
DI: 05414904027516
·
Model: CR MD4.0 GENERAL PLATE 8X10
·
AGFA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CR MD4.0 GENERAL PLATE
- Primary DI
- 05414904027516
- Version / Model
- CR MD4.0 GENERAL PLATE 8X10
- Catalog Number
- EJYZE
- Company Name
- AGFA
- Labeler DUNS
- 374444883
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 5
- Public Version Date
- 2026-02-13
- Public Version Status
- Update
- Public Device Record Key
- e79d53cb-242c-4891-b781-b669c46a2b05
- Distribution End Date
- 2026-01-30
Device Description
CR MD4.0 GENERAL PLATE 8X10I.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQB | Solid state x-ray imager (flat panel/digital imager) | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 67229 | Digital imaging phosphor plate, non-dental | A thin, photostimulable device intended to be placed in an appropriate light-shielding cassette (not included) and receive radiation by a diagnostic imaging x-ray system to record a radiation pattern of a patient’s bone(s) and/or organ(s) during a non-dental procedure. Following exposure, it is designed to be transferred in the cassette to a computed radiography (CR) scanner to produce a digital image of the latent image formed on the device. It is also known as a photostimulable phosphor (PSP) screen or storage plate. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05414904027516 | GS1 |
Customer Contacts
- Phone
- +1(877)777-2432
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Inch | |
| Width | 10 | Inch |