Identity
- Trade Name
- Surgical Probe Cover Kit FDA UDI
- Generic Name
- Intraoperative ultrasound imaging transducer cover FDA UDI
- Model / Reference
- 1930 FDA UDI
Identifiers
- Catalog Number
- 1930 FDA UDI
- Primary DI / UDI-DI
- 00841912100781 FDA UDI
- 510(k) Number
- K970889 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Intraoperative ultrasound imaging transducer cover 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
Yes
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: Intraoperative ultrasound imaging transducer cover
Surgical Probe Cover 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
K970889 also covers:
- MEDICAL ACTION INDUSTRIES — MEDICAL ACTION INDUSTRIES INC.
- Accuro Locator Needle Guide Kit — PROTEK MEDICAL PRODUCTS, INC.
- Auto Suture Gamma Probe Drape — PROTEK MEDICAL PRODUCTS, INC.
- Finesse Ultra, Sterile Instrument Cover with PullUp Insert — PROTEK MEDICAL PRODUCTS, INC.
- General Purpose Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Neoprobe Sterile Sleeve Kit with PullUp/pull off extension — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Probe Storage Covers — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Probe Storage Covers — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Probe Storage Covers — PROTEK MEDICAL PRODUCTS, INC.
- ProV-Access Vascular Access Needle Guide Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- ProV-Access Vascular Access Needle Guide Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- ProV-Access Vascular Access Needle Guide 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 8a2ff57d-93a9-46c1-a29f-3951ba6c225f 34 fields · synced May 30, 2026