FDA UDI
In Commercial Distribution
🇺🇸 United States
Built-up cap for ION Chambers
DI: EIBASA640000
·
Model: SA64-000
·
IBA Dosimetry GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Built-up cap for ION Chambers
- Primary DI
- EIBASA640000
- Version / Model
- SA64-000
- 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
- 46349dbc-9201-4e73-b4e9-eca77a849411
Device Description
50 mm diameter for 10 - 15 MV photon and > 18 MeV electron
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | EIBASA640000 | HIBCC |
Customer Contacts
- Phone
- +49912860738
- [email protected]
- Phone
- +861080809107
- [email protected]
- Phone
- +1 901 386-2242
- [email protected]