FDA UDI
In Commercial Distribution
🇺🇸 United States
DIRECTVIEW CR Gridded Cassette with PQ Screen
DI: 40889978645448
·
Model: DIRECTVIEW CR Gridded Cassette with PQ Screen
·
CARESTREAM HEALTH, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DIRECTVIEW CR Gridded Cassette with PQ Screen
- Primary DI
- 40889978645448
- Version / Model
- DIRECTVIEW CR Gridded Cassette with PQ Screen
- Catalog Number
- 8645442
- Company Name
- CARESTREAM HEALTH, INC.
- Labeler DUNS
- 793169512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-16
- Public Version
- 4
- Public Version Date
- 2024-06-19
- Public Version Status
- Update
- Public Device Record Key
- fcc00d4a-b347-43ff-bdc0-8fa1562fa42b
Device Description
DIRECTVIEW CR Cassett with PQ Scrn 35x35
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| IXJ | Grid, radiographic | Radiology | 892.1910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44824 | Digital imaging cassette/phosphor plate | A device that includes both a digital imaging cassette and a phosphor plate (also known as screen) intended to receive radiation by a diagnostic x-ray system, to record a patient radiation pattern during a non-dental procedure. The device is then transferred, with the cassette shielding the plate from environmental light, to a computed radiography (CR) scanner for insertion to produce the digital image of the patient. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 60889978645442 | GS1 | Case | 5 | In Commercial Distribution | |
| Primary | 40889978645448 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 24 Degrees Celsius