Identity
- Trade Name
- Sterile Disposable Endocavity Needle Guide Kit FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Sterile Disposable Endocavity Needle Guide Kit for use with Hitachi EUP-V33, EUP-V33W, EUP-V53W, EUP-V12, EUP-CC31, EUP-CC531, EZU-PA5V, C41V, CC41R & CC41R1, and Sonoscape 6V3 (2015 Model & Older) Ultrasound Transducers FDA UDI
- Model / Reference
- 5388 FDA UDI
- Description
- Sterile Disposable Endocavity Needle Guide Kit for use with Hitachi EUP-V33, EUP-V33W, EUP-V53W, EUP-V12, EUP-CC31, EUP-CC531, EZU-PA5V, C41V, CC41R & CC41R1, and Sonoscape 6V3 (2015 Model & Older) Ultrasound Transducers FDA UDI
Identifiers
- Catalog Number
- 5388 FDA UDI
- Primary DI / UDI-DI
- 00841912106462 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-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
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K971115 also covers:
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- 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 6191ed2c-11aa-480a-9d83-46e48f84b1eb 35 fields · synced May 30, 2026