Identity
- Trade Name
- Sterile Disposable Endocavity Needle Guide Kit FDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
- Device Name
- Sterile Disposable Endocavity Needle Guide Kit for Samsung Medison E3-12A Ultrasound Transducer FDA UDI
- Model / Reference
- 5261 FDA UDI
- Description
- Sterile Disposable Endocavity Needle Guide Kit for Samsung Medison E3-12A Ultrasound Transducer FDA UDI
Identifiers
- Catalog Number
- 5261 FDA UDI
- Primary DI / UDI-DI
- 00841912105137 FDA UDI
- FDA Product Code
- ITX FDA UDIKKX FDA UDI
- GMDN Term
- Body-orifice ultrasound imaging transducer cover, basic 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-orifice ultrasound imaging transducer cover, basic
Sterile Disposable Endocavity Needle Guide Kit by Protek Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Body-orifice ultrasound imaging transducer cover, basic.
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- NeoGuard™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes — Sheathing Technologies, Inc. · Class II
- Sheathes3D Pre-Gelled — Sheathing Technologies, Inc. · Class II
- Sheathes — 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.
K971115 also covers:
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Reusable (Short Style) Stainless Steel Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Reusable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Reusable Stainless Steel Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Reusable Stainless Steel Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Reusable Stainless Steel Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
K971722 also covers:
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Reusable (Short Style) Stainless Steel Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Reusable Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Reusable Stainless Steel Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Reusable Stainless Steel Endocavity Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Reusable Stainless Steel Endocavity 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 b2734f6b-47cb-49a0-84b4-b8b92d7c1683 35 fields · synced Jun 1, 2026