Identity
- Trade Name
- Ultrashcallsondenabdeckung EUDAMEDSheathes3D FDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- Non-Sterile Ultrasound Probe Cover EUDAMEDSeamless Viral Barrier, Polyurethane, 2.5" x 2.1" Face x 12"L, Non-Sterile, Specialty Ultrasound Probe Cover, Rolled FDA UDI
- Model / Reference
- 83001 EUDAMEDFDA UDI
- Description
- Seamless Viral Barrier, Polyurethane, 2.5" x 2.1" Face x 12"L, Non-Sterile, Specialty Ultrasound Probe Cover, Rolled FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00842418101159 EUDAMED10842418101156 FDA UDI
- Basic UDI-DI
- 08424181C1PNSA9 EUDAMED
- 510(k) Number
- K153212 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 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
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
Sheathes3D 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
K153212 also covers:
- Sheathes3D — Sheathing Technologies, Inc.
- Sheathes3D — Sheathing Technologies, Inc.
- Sheathes3D — Sheathing Technologies, Inc.
- Sheathes3D — Sheathing Technologies, Inc.
- Sheathes3D — Sheathing Technologies, Inc.
- Sheathes3D — Sheathing Technologies, Inc.
- Sheathes3D — Sheathing Technologies, Inc.
- Sheathes3D — Sheathing Technologies, Inc.
- Sheathes3D — Sheathing Technologies, Inc.
- Sheathes3D — Sheathing Technologies, Inc.
- Sheathes3D — Sheathing Technologies, Inc.
- Sheathes3D — 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 bcb30752-f0d2-403c-b08a-d39383cd5cfd 34 fields · synced Jun 14, 2026
- EUDAMED 49177a0c-22bb-4027-a9ee-4a5d20974941 61 fields · synced Jun 14, 2026