ImmobiLoc
ImmobiLoc Gas Release Short Profile Prostate Immobilization Treatment Balloon Device Kit W/60ml syringe
1manufacturer
5catalogue 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 | Radiadyne, L.L.C. |
|---|---|
| FDA product code | PCT |
| Device type | Prostate Immobilizer Rectal Balloon |
| Device class | Class 2 |
| Regulation | 21 CFR 892.5720 |
| 510(k) | DEN130036 |
| Record published | 2016-09-12 |
| Record revised | 2024-11-05 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -30 to 50 °C |
| Packaging | Shipper box of 5, shelf package of 20, shelf box of 20, shelf carton of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ILG-60F | In distribution | |
| ILG-90F | In distribution | |
| IL-100 | In distribution | |
| IL-60 | In distribution | |
| ILG-60F-60ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prostate Caddy Rectal Balloon | Myriad Medical LLC | 3 |
| IsoLoc | Radiadyne, L.L.C. | 3 |
| Qlrad | Qlrad | 3 |
| Bionix Radiation Therapy | Bionix Radiation Therapy, LLC | 2 |
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.