← Back to catalogue
Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C41 Ultrasound Transducers FDA UDI
- Model / Reference
- 5364 FDA UDI
- Description
- Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit for use with DBSI2C for Esaote SI2C41 Ultrasound Transducers FDA UDI
Identifiers
- Catalog Number
- 5364 FDA UDI
- Primary DI / UDI-DI
- 00841912106905 FDA UDI
- FDA Product Code
- ITX FDA UDIKKX FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI878.4370 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
Yes
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
Yes
FDA UDI
Category: Needle guide, single-useBody-surface ultrasound imaging transducer cover
Sterile Single-Use Multi-Angle Needle Guide-Probe Cover Kit by Protek Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Body-surface ultrasound imaging transducer cover.
- Sheathes3D — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes3D — Sheathing Technologies, Inc. · Class II
- Sheathes3D — Sheathing Technologies, Inc. · Class II
- Sheathes3D — Sheathing Technologies, Inc. · Class II
Cleared under the same submission
K970893 also covers:
- Coveralls — H R Pharmaceuticals, Inc.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Probe Cover — PROTEK MEDICAL PRODUCTS, INC.
- General Purpose Probe Cover — PROTEK MEDICAL PRODUCTS, INC.
- General Purpose Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- General Purpose Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- General Purpose Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
K973958 also covers:
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director XT Multi Gauge Needle Guide — PROTEK MEDICAL PRODUCTS, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Protek Medical Products, Inc.
Sources (1)
- FDA UDI 85be8e01-bf80-4a76-9530-5e1faef820c5 35 fields · synced May 29, 2026