Identity
- Trade Name
- Sheathes3D FDA UDI
- Generic Name
- Intraoperative ultrasound imaging transducer cover FDA UDI
- Device Name
- Seamless Viral Barrier Contour T-End, Latex-Free, 2.1" x 0.5" Face to 6"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled FDA UDI
- Model / Reference
- 50040-IT966 FDA UDI
- Description
- Seamless Viral Barrier Contour T-End, Latex-Free, 2.1" x 0.5" Face to 6"W x 96"L, Sterile, Extended Field Ultrasound Probe & Cord Cover with 2 Elastics, Rolled FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10842418102337 FDA UDI
- 510(k) Number
- K153212 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Intraoperative ultrasound imaging transducer cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intraoperative ultrasound imaging transducer cover
Sheathes3D by Sheathing Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoperative ultrasound imaging transducer cover.
- Ultrasound Pad — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Surgical Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- MICROTEK — Microtek Medical LLC · Class II
- MICROTEK — Microtek Medical LLC · Class II
- PullUp Surgical Probe Cover — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Sterile Single-Use Surgical Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- MICROTEK — Microtek Medical LLC · Class II
- Sterile Single-Use Surgical Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sheathing Technologies, Inc.
Sources (1)
- FDA UDI 825ef717-b07d-45e6-af16-9d942bbd8799 34 fields · synced Jun 9, 2026