Bionix Radiation Therapy
Endorectal Balloon
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Koo (Shanghai) Industries Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 9 |
Record
| Listed by | Bionix Radiation Therapy, LLC |
|---|---|
| FDA product code | PCT |
| Device type | Prostate Immobilizer Rectal Balloon |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5720 |
| Record published | 2017-04-25 |
| Record revised | 2023-07-10 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: STORE IN A COOL, DRY ENVIRONMENT |
| Packaging | Box of 12 |
| Sizes | Outer diameter 41.5 mm; length 90 mm |
| Distribution end date | 2019-08-30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ERB-90-FS | OUTER DIAMETER | Withdrawn |
| ERB-90-SS | OUTER DIAMETER | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ImmobiLoc | Radiadyne, L.L.C. | 5 |
| Prostate Caddy Rectal Balloon | Myriad Medical LLC | 3 |
| IsoLoc | Radiadyne, L.L.C. | 3 |
| Qlrad | Qlrad | 3 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.