Bioprotect Balloon Implant System
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Basic Information
- Primary DI
- D-72900148787D
- Basic UDI-DI Code
- B-72900148787D
- Reference
- 0135
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- BioProtect
Additional Description
The BioProtect Balloonโข Implant System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the BioProtect Balloonโข Implant System to reduce the radiation dose delivered to the anterior rectum. The BioProtect Balloonโข Implant System is a balloon made of a biodegradable material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patientโs body over time.
CND Nomenclature Codes
| Code | Description |
|---|---|
| V9099 | VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex V | 2116136CE01 | DEKRA Certification B.V. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).