Identity
- Trade Name
- CIV-Flex™ Transducer Cover EUDAMEDFDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- General Purpose and Intraoperative Covers (CIV-Flex sterile) EUDAMEDSterile (14 x 147cm) telescopically-folded cover for use with BK Medical 6C2, 6C2s, 9C2, 8801, 8802, 8820e, 8823 and 8830 transducers FDA UDI
- Model / Reference
- UA0076 EUDAMEDFDA UDI
- Description
- Sterile (14 x 147cm) telescopically-folded cover for use with BK Medical 6C2, 6C2s, 9C2, 8801, 8802, 8820e, 8823 and 8830 transducers FDA UDI
Identifiers
- Catalog Number
- UA0076 FDA UDI
- Primary DI / UDI-DI
- 10841436110386 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD201A1NJ EUDAMED
- 510(k) Number
- K970513 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
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Length — 147 Centimeter FDA UDIWidth — 14 Centimeter FDA UDI
Category: Body-surface ultrasound imaging transducer cover
CIV-Flex™ 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
K970513 also covers:
- Brachytherapy Kit 3 — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Guide Sheath — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- CIV-Flex™ Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (2)
- FDA UDI a915864a-4e9b-4649-aa16-d7a5e6a81301 38 fields · synced Oct 6, 2026
- EUDAMED 80a304b1-849e-4348-aa2a-cd594c4559c6 61 fields · synced Oct 6, 2026