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Sign in to claim this brandSheathing Technologies, Inc.
United States·US-MF-000044559
Last updated September 17, 2026
About
Sheathing Technologies, Inc. is headquartered in Morgan Hill, California. We offer the most extensive selection of medical probe cover sizes and shapes available.
From the manufacturer's own website. Source
Information
- Country
- United States
- Address
- 675 , Jarvis Drive, Morgan Hill, United States
- Website
- www.sheathes.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Gretchen Olson
- EUDAMED SRN
- US-MF-000044559
- FDA FEI Number
- 1000135740
- DUNS Number
- —
Catalogue (491)
Page 9 of 10| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sheathes | 50040-961CT | FDA UDI | Class II | Active |
| Sheathes | 5-30740 | FDA UDI | Class II | Active |
| Sheathes | 30355-ACP | FDA UDI | Class II | Active |
| Sheathes | 25021 | FDA UDI | Class II | Active |
| Sheathes | 50001-246 | FDA UDI | Class II | Active |
| Sheathes3D | 5-2445T | FDA UDI | Class II | Active |
| Sheathes Pre-Gelled | 47090 | FDA UDI | Class II | Active |
| Sheathes Pre-Gelled | 50001-27964 | FDA UDI | Class II | Active |
| Sheathes3D | 5-357-IL586 | FDA UDI | Class II | Active |
| Sheathes | 5-9655 | FDA UDI | Class II | Active |
| Sheathes3D | 76440 | FDA UDI | Class II | Active |
| Sheathes | 50040-301 | FDA UDI | Class II | Active |
| Sheathes3D | ADH-5-IL246 | FDA UDI | Class II | Active |
| Sheathes3D | 75303VCI | FDA UDI | Class II | Active |
| Sheathes | 5-586 | FDA UDI | Class II | Active |
| Sheathes | 50040-26364 | FDA UDI | Class II | Active |
| Sheathes3D | ADH-65-IL486-12110-3 | FDA UDI | Class II | Active |
| Sheathes | T40AP | FDA UDI | Class II | Active |
| Sheathes | 20340 | FDA UDI | Class II | Active |
| Sheathes3D | 5-IL586 | FDA UDI | Class II | Active |
| Sheathes3D | 80301 | FDA UDI | Class II | Active |
| Sheathes | 35786 | FDA UDI | Class II | Active |
| Sheathes | 10720 | FDA UDI | Class II | Active |
| SheathesISO | 70336 | FDA UDI | Class II | Active |
| Sheathes | 50040-246 | FDA UDI | Class II | Active |
| Sheathes | 10001 | FDA UDI | Class II | Active |
| Sheathes3D | 5-IR966 | FDA UDI | Class II | Active |
| Sheathes | 5-363 | FDA UDI | Class II | Active |
| Sheathes | 65-486-22110-3 | FDA UDI | Class II | Active |
| Sheathes3D | 5-IL486 | FDA UDI | Class II | Active |
| Sheathes3D | 74001 | FDA UDI | Class II | Active |
| Sheathes | 50040-963 | FDA UDI | Class II | Active |
| Sheathes3D | 5-1245 | FDA UDI | Class II | Active |
| Sheathes | 50001-363 | FDA UDI | Class II | Active |
| Sheathes | 5-961 | FDA UDI | Class II | Active |
| Sheathes | 26839 | FDA UDI | Class II | Active |
| Sheathes | 5-80040 | FDA UDI | Class II | Active |
| Sheathes | 26303 | FDA UDI | Class II | Active |
| Sheathes3D | ADH-65-IL966-12110-3 | FDA UDI | Class II | Active |
| Sheathes | 5-83740 | FDA UDI | Class II | Active |
| Sheathes | 50040-25484 | FDA UDI | Class II | Active |
| Sheathes | 5-966NS | FDA UDI | Class II | Active |
| Sheathes3D | 5-357-IH586 | FDA UDI | Class II | Active |
| Sheathes | 5-964 | FDA UDI | Class II | Active |
| Sheathes3D | 5-357-IL726 | FDA UDI | Class II | Active |
| Sheathes3D | 5-357-IH486 | FDA UDI | Class II | Active |
| Sheathes | 9-47380 | FDA UDI | Class II | Active |
| Sheathes Pre-Gelled | 47080 | FDA UDI | Class II | Active |
| Sheathes3D Pre-Gelled | 77380 | FDA UDI | Class II | Active |
| Sterile, Ultrasound Probe Cover with 2 Elastics, Rolled | 35740 (ITL) | EUDAMED | Class I | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Nov 17, 2025 | Z-1006-2026 | — | open, classified | Vaginal/rectal ultrasound probe covers with a viral barrier may have product defects, which may result in contamination during use, posing an infection risk. |