Identity
- Trade Name
- Ultrashcallsondenabdeckung EUDAMEDSheathes FDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
- Device Name
- Sterile Extended Field Ultrasound Probe Cover EUDAMEDPolyurethane, 7/8"D Tapered to 4"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Vaginal/Rectal, Folded FDA UDI
- Model / Reference
- 50040-26964 EUDAMEDFDA UDI
- Description
- Polyurethane, 7/8"D Tapered to 4"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Vaginal/Rectal, Folded FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842418101678 EUDAMED10842418101675 FDA UDI
- Basic UDI-DI
- 08424181C2PSEX EUDAMED
- 510(k) Number
- K990175 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 IIa 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
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
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
Similar devices
Also classified as Body-orifice ultrasound imaging transducer cover, basic.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Endocavity Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC. · Class II
- NeoGuard™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Short Style Endocavity Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Endocavity Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Sterile Disposable Endocavity Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
Cleared under the same submission
K990175 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sheathing Technologies, Inc.
Sources (2)
- FDA UDI 94aecfdb-271c-4e1c-b753-83efa0f2a487 34 fields · synced Jul 8, 2026
- EUDAMED 2308be20-8138-48fd-945c-acc322d56a59 61 fields · synced Jul 8, 2026