FDA UDI
In Commercial Distribution
🇺🇸 United States
Multimeter MagicMax PT - rad/flu/dent with special calibtation
DI: EIBADP02019400
·
Model: DP0201940
·
IBA Dosimetry GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Multimeter MagicMax PT - rad/flu/dent with special calibtation
- Primary DI
- EIBADP02019400
- Version / Model
- DP0201940
- Catalog Number
- DP0201940
- Company Name
- IBA Dosimetry GmbH
- Labeler DUNS
- 332599307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-26
- Public Version
- 2
- Public Version Date
- 2022-07-04
- Public Version Status
- Update
- Public Device Record Key
- 3cc779d4-a15a-4bf4-823f-34b6d5e31868
Device Description
Multimeter with fixed XR Multidetector. The solution for exact dose- and kV-measurements at kV-imager of Proton Therapy Systems.
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
- Yes
- 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 |
|---|---|---|---|---|
| LHO | Instrument, Quality-Assurance, Radiologic | Radiology | 892.1940 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38385 | Diagnostic x-ray system quality assurance device | An instrument intended to be used to assess the performance of diagnostic x-ray equipment for quality assurance (QA) purposes; it is typically intended to measure, display, and record one or more x-ray parameter(s) [e.g., kVp, mAs, dose, exposure time]. It may be placed in the field of view and/or be connected to the x-ray equipment, and may have various forms (e.g., handheld or desktop unit with sensor and dedicated software). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EIBADP02019400 | HIBCC |
Customer Contacts
- Phone
- +1 786 288 0369
- [email protected]
- Phone
- +861080809288
- [email protected]
- Phone
- +49912860738
- [email protected]