Medrad® PRO-Tekt Endorectal Balloon
MEDRAD PRO-TEKT Endorectal Balloon (PRO-TEKT Endorectal Balloon, PROT50) (60729377)
1manufacturer
1catalogue number
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Bayer Medical Care Inc., United States |
|---|---|
| FDA product code | EXX |
| Device type | Probe, Rectal, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2019-03-11 (version 3) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PROT 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Marina Medical | Marina Medical Instruments, Inc. | 12 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 9 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 8 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 6 |
| Novo Surgical | Novo Surgical, Inc. | 6 |
| Aesculap | Aesculap AG | 6 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 5 |
| V. Mueller | Steris Corporation | 4 |
| Millennium | Avalign Technologies, Inc. | 2 |
| Gimmi | Gimmi Gmbh | 2 |
| BR Surgical, LLC | BR Surgical LLC | 1 |
| Ambler Surgical | Ambler Surgical, LLC | 1 |
Showing 12 of 14. All products under Probe, Rectal, Non-Powered
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.