Identity
- Trade Name
- Non-Sterile Probe Cover Kits FDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, basic, non-sterile FDA UDI
- Model / Reference
- 0137 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841912104185 FDA UDI
- 510(k) Number
- K970893 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Body-orifice ultrasound imaging transducer cover, basic, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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: Body-orifice ultrasound imaging transducer cover, basic, non-sterile
Non-Sterile Probe Cover Kits 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:
- 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 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.
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 |
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Manufacturer
- Manufacturer
- Protek Medical Products, Inc.
Sources (1)
- FDA UDI b2a2235f-9560-4aed-8da9-6e52242e1cdb 34 fields · synced Jun 6, 2026