FDA UDI
In Commercial Distribution
🇺🇸 United States
IMRT - Bodyphantom
DI: EIBAM98000000
·
Model: M9800000
·
IBA Dosimetry GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- IMRT - Bodyphantom
- Primary DI
- EIBAM98000000
- Version / Model
- M9800000
- Catalog Number
- BS40-000
- 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
- 4
- Public Version Date
- 2023-04-13
- Public Version Status
- Update
- Public Device Record Key
- 8cf08132-26f5-420d-b00d-4423591e4fc0
Device Description
IMRT - Bodyphantom
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
- 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 |
|---|---|---|---|---|
| 38399 | Accelerator system quality assurance device | An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | EIBAM98000001 | HIBCC | Carry Case | 1 | In Commercial Distribution | |
| Primary | EIBAM98000000 | HIBCC |
Customer Contacts
- Phone
- +49912860738
- [email protected]
- Phone
- +861080809107
- [email protected]
- Phone
- +1 901 386-2242
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031634 | 000 |