Identity
- Trade Name
- MICROTEK FDA UDI
- Generic Name
- Intraoperative ultrasound imaging transducer cover FDA UDI
- Device Name
- ULTRASOUND T-SHAPED PROBE CVR, 1-EACH FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- ULTRASOUND T-SHAPED PROBE CVR, 1-EACH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00748426045976 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Category: Intraoperative ultrasound imaging transducer cover
Microtek by Microtek Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoperative ultrasound imaging transducer cover.
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- Sheathes3D — Sheathing Technologies, Inc. · Class II
- Sterile Single-Use Surgical Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Sterile Single-Use Surgical Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
- PullUp Surgical Probe Cover — PROTEK MEDICAL PRODUCTS, INC. · Class II
- PullUp Surgical Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC. · Class II
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
- Microtek Medical LLC
Sources (1)
- FDA UDI db37ed65-c34b-4c64-a233-f1c490efa9fd 35 fields · synced Jun 8, 2026