Identity
- Trade Name
- MICROTEK FDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, basic, non-sterile FDA UDI
- Device Name
- ROLLED PROBE COVER FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- ROLLED PROBE COVER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00748426120956 FDA UDI
- 510(k) Number
- K882724 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
Yes
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Body-orifice ultrasound imaging transducer cover, basic, non-sterile
Microtek by Microtek Medical LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Body-orifice ultrasound imaging transducer cover, basic, non-sterile.
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- Short Style Endocavity Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Endocavity Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Non-Sterile Latex Endocavity Probe Cover — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Rolled Probe Cover and Bands — PROTEK MEDICAL PRODUCTS, INC. · Class II
- SheathesISO — Sheathing Technologies, Inc. · Class II
Cleared under the same submission
K882724 also covers:
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
- MICROTEK — Microtek Medical LLC
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
- Microtek Medical LLC
Sources (1)
- FDA UDI 99e1c484-0a7b-4924-9235-77b9dab3cfee 36 fields · synced Jun 8, 2026