Identity
- Trade Name
- Ultrashcallsondenabdeckung EUDAMEDSheathes FDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- Sterile Extended Field Ultrasound Probe Cover EUDAMEDPolyurethane, 3.5"W x 24"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled FDA UDI
- Model / Reference
- 50040-2435 EUDAMEDFDA UDI
- Description
- Polyurethane, 3.5"W x 24"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842418101609 EUDAMED10842418101606 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-surface ultrasound imaging transducer cover 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-surface ultrasound imaging transducer cover
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-surface ultrasound imaging transducer cover.
- Director Biopsy/Needle Guide/PullUp Probe Cover Kits — PROTEK MEDICAL PRODUCTS, INC.
- Multi Angle Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- envision Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- MICROTEK — Microtek Medical LLC · Class II
- Henry Schein — HENRY SCHEIN, 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 e67157c3-1be9-4f13-807c-8bb7005dd1c7 34 fields · synced Jul 22, 2026
- EUDAMED 3f97debd-ae59-4dab-8053-588c0b0ba4e6 61 fields · synced Jul 22, 2026