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 use with Alpinion E3-10, BK Medical 8819 & E10C4, Carestream E10C4 & E14C4, Hitachi Aloka Medical UST-679, Philips BP10-5ec (Affiniti 50, Affiniti 70, HD11, HD115 & HD7XE systems) & C9-4ec (HD7 XE w/3.0.1, software and above & HD9 systems) and Samsung Medison NEV4-9ES & NER4-9ES Ultrasound Transducers FDA UDI
- Model / Reference
- 5252 FDA UDI
- Description
- Sterile Disposable Endocavity Needle Guide Kit for use with Alpinion E3-10, BK Medical 8819 & E10C4, Carestream E10C4 & E14C4, Hitachi Aloka Medical UST-679, Philips BP10-5ec (Affiniti 50, Affiniti 70, HD11, HD115 & HD7XE systems) & C9-4ec (HD7 XE w/3.0.1, software and above & HD9 systems) and Samsung Medison NEV4-9ES & NER4-9ES Ultrasound Transducers FDA UDI
Identifiers
- Catalog Number
- 5252 FDA UDI
- Primary DI / UDI-DI
- 00841912106073 FDA UDI
- FDA Product Code
- KKX FDA UDIITX FDA UDI
- GMDN Term
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI892.1570 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
Yes
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
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Cleared under the same submission
K970891 also covers:
- Latex Endocavity Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Latex Endocavity Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Latex Endocavity Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Latex Endocavity Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Latex Endocavity Probe Cover — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Latex Endocavity Probe Cover — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Latex Endocavity Probe Cover — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Latex Endocavity Probe Cover — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Latex Endocavity Probe Cover — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Latex Endocavity Probe Cover — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Latex Endocavity Probe Cover — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Latex Endocavity Probe Cover — 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 4762c553-5268-433f-bfd6-5b9903e1c900 35 fields · synced May 30, 2026