FDA UDI
In Commercial Distribution
🇺🇸 United States
REGIUS Cassette/Plate
DI: 04560141930902
·
Model: KCMM
·
KONICA MINOLTA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- REGIUS Cassette/Plate
- Primary DI
- 04560141930902
- Version / Model
- KCMM
- Company Name
- KONICA MINOLTA, INC.
- Labeler DUNS
- 692076161
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 6
- Public Version Date
- 2024-06-19
- Public Version Status
- Update
- Public Device Record Key
- ede5f726-5e7a-4448-9653-e0ec75a83bd8
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| 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/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 |
|---|---|---|---|---|---|---|
| Primary | 04560141930902 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K092717 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 11" x 14" |