Identity
- Trade Name
- RetroFit XT Multi Gauge Needle Guide Kit FDA UDI
- Generic Name
- Cable/lead/sensor/probe cover, sterile FDA UDI
- Model / Reference
- 5601 FDA UDI
Identifiers
- Catalog Number
- 5601 FDA UDI
- Primary DI / UDI-DI
- 00841912104406 FDA UDI
- FDA Product Code
- KKX FDA UDIITX FDA UDI
- GMDN Term
- Cable/lead/sensor/probe cover, sterile 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
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-useCable/lead/sensor/probe cover, sterile
RetroFit XT Multi Gauge 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
K970893 also covers:
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- 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 Kit — PROTEK MEDICAL PRODUCTS, INC.
- General Purpose Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- General Purpose Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Endocavity 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 027a5fcf-d12f-42f1-b26d-2430b44f7578 34 fields · synced Jun 8, 2026