Marina Medical
Supracervical Probe w/Solid Ø5cm Concave Tip, Green Handle (NON-RETURNABLE)
1manufacturer
12catalogue numbers in this listing
1recall
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 | Marina Medical Instruments, Inc., United States |
|---|---|
| FDA product code | EXX |
| Device type | Probe, Rectal, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-10 |
| Record revised | 2025-02-13 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Sizes | Length 4 to 29.5 cm; length 5 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 280-109 | In distribution | |
| 042-045 | In distribution | |
| 340-252 | Length 29.5 cm | In distribution |
| 350-255A | Length 5 cm | In distribution |
| 189-904 | In distribution | |
| 042-013 | Length 5 in | In distribution |
| 350-254A | Length 4 cm | In distribution |
| 350-370A | In distribution | |
| 189-905 | In distribution | |
| 042-046 | In distribution | |
| 210-240 | Length 19.7 cm | In distribution |
| 350-255B | Length 5 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| GreenEgg | Endoglow, LLC | 1 |
Showing 12 of 14. All products under Probe, Rectal, Non-Powered
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-04-09 | Not classified | Nonconforming Material/Component | Marina Medical, Sunrise, FL initiated recall of 46 different 350 series devices and 47 different 270 series products because the material used to manufacture the products was not proven to be biocompatible, resulting in risk of temporary sk | 47 | 2010-09-03 |
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.