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Sterile Disposable Endocavity Needle Guide / System Drape Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Sterile Disposable Endocavity Needle Guide / System Drape Kit FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, sterile FDA UDI
- Model / Reference
- 5280 FDA UDI
Identifiers
- Catalog Number
- 590-03001-00 FDA UDI
- Primary DI / UDI-DI
- 00841912104963 FDA UDI
- FDA Product Code
- MMP FDA UDIKKX FDA UDIITX FDA UDI
- GMDN Term
- Instrument/equipment drape, single-use, 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
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-useInstrument/equipment drape, single-use, sterileBody-orifice ultrasound imaging transducer cover, basic
Sterile Disposable Endocavity Needle Guide / System Drape Kit by Protek Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K970885 also covers:
- CT Control Cover — PROTEK MEDICAL PRODUCTS, INC.
- CT Control Cover with Arm Bands — PROTEK MEDICAL PRODUCTS, INC.
- CT Control Cradle Cover — PROTEK MEDICAL PRODUCTS, INC.
- CT Control Rail Cover — PROTEK MEDICAL PRODUCTS, INC.
- CT Cover Procedure Kit — PROTEK MEDICAL PRODUCTS, INC.
- CT Monitor Cover — PROTEK MEDICAL PRODUCTS, INC.
- ClingTouch Sterile Disposable Monitor Cover — PROTEK MEDICAL PRODUCTS, INC.
- ClingTouch Sterile Disposable Monitor Cover — PROTEK MEDICAL PRODUCTS, INC.
- Cord Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Instrument Cover — PROTEK MEDICAL PRODUCTS, INC.
- Instrument Cover with PullUp Insert — PROTEK MEDICAL PRODUCTS, INC.
- Isoloader Surgical Drape — PROTEK MEDICAL PRODUCTS, INC.
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 f6bc4024-4f1f-406c-a0ee-302ae994bdea 35 fields · synced May 31, 2026