Identity
- Trade Name
- CIV-Clear™ Transducer Cover EUDAMEDFDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- General Purpose and Intraoperative Covers (CIV-Clear non-sterile) EUDAMEDNon-sterile (14x61cm) flat-folded cover FDA UDI
- Model / Reference
- 610-2389 EUDAMEDFDA UDI
- Description
- Non-sterile (14x61cm) flat-folded cover FDA UDI
Identifiers
- Catalog Number
- 610-2389 FDA UDI
- Primary DI / UDI-DI
- 00841436121248 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD201A10RH EUDAMED
- Unit of Use DI
- 80841436121244 EUDAMED
- 510(k) Number
- K211270 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- T030102 COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS EUDAMED
- GMDN Term
- Body-surface ultrasound imaging transducer cover FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Body-surface ultrasound imaging transducer cover
CIV-Clear™ Transducer Cover by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (2)
- FDA UDI ee1a6e40-7472-4932-99ab-45b4ac8ccf9e 37 fields · synced Oct 6, 2026
- EUDAMED 3bb74bb0-45b4-4da0-92bd-62b3f434f929 61 fields · synced Oct 6, 2026