CIV-Flex wireless transducer covers
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- CIV-Flex wireless transducer covers EUDAMEDFDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- General Purpose and Intraoperative Covers (CIV-Flex sterile) EUDAMEDSterile (14 × 29.2cm) telescopically-folded wireless transducer cover FDA UDI
- Model / Reference
- 11003359 EUDAMEDFDA UDI
- Description
- Sterile (14 × 29.2cm) telescopically-folded wireless transducer cover FDA UDI
Identifiers
- Catalog Number
- 11003359 FDA UDI
- Primary DI / UDI-DI
- 00841436110662 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD201A1NJ EUDAMED
- Unit of Use DI
- 80841436110668 EUDAMED
- 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
Yes
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
Dimensions & Sizes
- Size
- Length — 12 Inch FDA UDIWidth — 5.5 Inch FDA UDI
Category: Body-surface ultrasound imaging transducer cover
CIV-Flex wireless transducer covers by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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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 bda52151-39e6-44d5-b011-031d957017e0 37 fields · synced Oct 6, 2026
- EUDAMED d03b5ff9-212b-448e-aef9-522de188ec01 61 fields · synced Jul 10, 2026