FDA UDI
In Commercial Distribution
🇺🇸 United States
iBEAM
DI: 04056719001322
·
Model: P10105-423
·
3C-Medical Intelligence GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- iBEAM
- Primary DI
- 04056719001322
- Version / Model
- P10105-423
- Catalog Number
- P10105-423
- Company Name
- 3C-Medical Intelligence GmbH
- Labeler DUNS
- 314546664
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-23
- Public Version
- 4
- Public Version Date
- 2023-12-15
- Public Version Status
- Update
- Public Device Record Key
- b6241f56-e480-4bb4-8bb9-d684e32d8ff2
Device Description
The iBEAM® evo Extension 650 is designed to support the patients upper body and extends off the end of the iBEAM® evo Couchtop by 650 mm, thus allowing for treatment of the prostate in very tall patients.
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 |
|---|---|---|---|---|
| IXQ | Table, Radiographic, Stationary Top | Radiology | 892.1980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40686 | Accelerator system table, non-powered | A non-electrical radiotherapy device that is a component of an accelerator system specifically designed to position and support a patient, typically supine, during therapeutic radiation treatments administered using a medical linear accelerator or non-linear accelerator. It is a flat surface on legs with fixed position top or mechanical top positioning and/or height controls (e.g., pneumatic controls, magnetic locks, cranks and lever mechanisms). It may be an independent device that is stationary or mobile, or it can be an integral component of a medical accelerator system design. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04056719001322 | GS1 |