Identity
- Trade Name
- Sheathes FDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
- Device Name
- Non-Sterile Ultrasound Probe Cover EUDAMEDLatex, 1.25"D x 8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamless, Straight, Rolled FDA UDI
- Model / Reference
- 10021 EUDAMEDFDA UDI
- Description
- Latex, 1.25"D x 8"L, Non-Sterile, Ultrasound Probe Cover, Vaginal/Rectal, Seamless, Straight, Rolled FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842418100039 EUDAMED10842418100036 FDA UDI
- Basic UDI-DI
- 08424181C1PNSA9 EUDAMED
- 510(k) Number
- K925869 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
- GMDN Term
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
Yes
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Body-orifice ultrasound imaging transducer cover, basic
Sheathes by Sheathing Technologies, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K925869 also covers:
- Sheathes — Sheathing Technologies, Inc.
- Sheathes — Sheathing Technologies, Inc.
- Sheathes — Sheathing Technologies, Inc.
- Sheathes — Sheathing Technologies, Inc.
- Sheathes — Sheathing Technologies, Inc.
- Sheathes — Sheathing Technologies, Inc.
- Sheathes — Sheathing Technologies, Inc.
- Sheathes — Sheathing Technologies, Inc.
- Sheathes — Sheathing Technologies, Inc.
- Sheathes — Sheathing Technologies, Inc.
- Sheathes — Sheathing Technologies, Inc.
- Sheathes — Sheathing Technologies, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sheathing Technologies, Inc.
Sources (2)
- FDA UDI b98fe839-f0ef-4beb-a01e-61080d7779d0 34 fields · synced Jun 19, 2026
- EUDAMED ff6664ad-6a00-4f6a-9f57-0dc398c33134 61 fields · synced Jun 19, 2026