FDA UDI
In Commercial Distribution
🇺🇸 United States
CR HD5.0 FLFS CASSETTE
DI: 05414904040539
·
Model: CR HD5.0 FLFS CASSETTE 35X43
·
AGFA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CR HD5.0 FLFS CASSETTE
- Primary DI
- 05414904040539
- Version / Model
- CR HD5.0 FLFS CASSETTE 35X43
- Catalog Number
- E1WE2
- 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
- 2024-06-19
- Public Version Status
- Update
- Public Device Record Key
- 8572b00e-d8e7-4d29-9a8c-5172cf4b12c7
Device Description
CR HD5.0 FLFS CASSETTE 35X43CM
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 |
|---|---|---|---|---|
| 44823 | Digital imaging cassette | A device intended to be used in diagnostic x-ray imaging to hold and shield a phosphor plate (not included) from exposure to room light during transport and insertion into a computed radiography (CR) scanner to produce a digital image of a patient radiation pattern. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05414904040539 | GS1 |
Customer Contacts
- Phone
- +1(877)777-2432
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141602 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 35 | Centimeter | |
| Width | 43 | Centimeter |