| Brand Name | ENDODRY |
| Common Device Name | Storage and Drying Cabinet |
| Manufacturer (Section D) |
| STERIS Corporation |
| 6100 heisley road |
| mentor OH 44060 |
|
| Manufacturer (Section G) |
| STERIS Corporation |
| 6100 heisley road |
|
| mentor OH 44060 |
|
| Manufacturer Contact |
|
daniel
davy
|
| 5960 heisley road |
| mentor, OH 44060
|
|
+1(440)259-7401
|
|
| MDR Report Key | 50014211 |
| Report Number | 3003950207-2026-00016 |
| Device Sequence Number | 10547506 |
| Product Code |
PUP
|
| UDI-Device Identifier | 18011517151207 |
| Combination Product (Y/N) | N |
| Initial Reporter State | TX |
| Initial Reporter Country | US |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Serviced by Third Party (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
User Facility |
| Initial Reporter Occupation |
Other Health Care Professional
|
| Type of Report
| Initial |
| Report Date (Section B) |
07/24/2026 |
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
No
|
| Is this a Product Problem Report? |
Yes
|
| Operator of Device |
Health Professional
|
| Device Model Number | Storage and Drying Cabinet |
| Device Catalogue Number | 15120 |
| Was Device Available for Evaluation? |
Yes
|
| Is the Reporter a Health Professional? |
Yes
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 10/14/2025 |
| Initial Report FDA Received Date | 07/27/2026 |
| Was Device Evaluated by Manufacturer? (Y/N) |
Yes
|
| Date Device Manufactured | 01/17/2017 |
| Is the Device Labeled for Single Use? (Y/N) |
No
|
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N) |
No
|
| Usage of Device |
Reuse
|
| Patient Sequence Number | 1 |
| Patient Sex | Unknown |