FDA UDI
In Commercial Distribution
🇺🇸 United States
CC04 Ion chamber
DI: EIBADS030000
·
Model: DS03-000
·
IBA Dosimetry GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CC04 Ion chamber
- Primary DI
- EIBADS030000
- Version / Model
- DS03-000
- Company Name
- IBA Dosimetry GmbH
- Labeler DUNS
- 332599307
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 5d3d7132-1d43-4bb5-87a0-0258ca3a9ec4
Device Description
CC04 Ion chamber: 0.04 ccm, shonka plastic, waterproof, TNC triax, for stereotactic, IMRT or any small field measurements
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
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36596 | Radiation electrometer | A stand-alone external measuring device with a detection circuit that can be used with different ion chamber probes for conducting dosimetry measurements in high radiation fields. An electrometer typically includes output read out capabilities in charge, current, time, dose and dose rate. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EIBADS030001 | HIBCC | Chamber Case | 1 | In Commercial Distribution | |
| Primary | EIBADS030000 | HIBCC |
Customer Contacts
- Phone
- +1 901 386-2242
- [email protected]
- Phone
- +861080809107
- [email protected]
- Phone
- +49912860738
- [email protected]