FDA UDI
In Commercial Distribution
🇺🇸 United States
CR HD5.0 GENERAL DETECTOR
DI: 05414904015650
·
Model: CR HD5.0 GENERAL DETECTOR 35X43
·
AGFA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CR HD5.0 GENERAL DETECTOR
- Primary DI
- 05414904015650
- Version / Model
- CR HD5.0 GENERAL DETECTOR 35X43
- Catalog Number
- ERMO7
- Company Name
- AGFA
- Labeler DUNS
- 374444883
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 5
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- 1155a3ef-5bd0-496b-9127-a091adb0a3c9
Device Description
CR HD5.0 GENERAL DETECTOR 35CM X 43CM
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 44824 | Digital imaging cassette/storage phosphor screen, basic diagnostic x-ray | A combination device for medical imaging applications that consists of a cassette used to hold and shield an attached storage phosphor screen from exposure to room light during transport and insertion into a diagnostic imaging x-ray system, and a computed radiography scanner. The photostimulatable storage phosphor screen is exposed to radiation by the x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05414904015650 | GS1 |
Customer Contacts
- Phone
- +1(877)777-2432
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141602 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 43 | Centimeter | |
| Length | 35 | Centimeter |