Identity
- Trade Name
- CIV-Flex™ Transducer Cover EUDAMEDFDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
- Device Name
- Intracavity Covers (TEE CIV-Flex sterile) EUDAMEDSterile (4.6 tapered to 2.5 x 122cm) TEE cover on applicator FDA UDI
- Model / Reference
- 610-933 EUDAMEDFDA UDI
- Description
- Sterile (4.6 tapered to 2.5 x 122cm) TEE cover on applicator FDA UDI
Identifiers
- Catalog Number
- 610-933 FDA UDI
- Primary DI / UDI-DI
- 10841436104477 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD201C8P6 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-orifice ultrasound imaging transducer cover, basic 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
- Width — 1.5 Inch FDA UDILength — 4.25 Inch FDA UDI
Category: Body-orifice ultrasound imaging transducer cover, basic
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
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 4a4d84df-139c-4d82-9d5b-44001128e975 38 fields · synced Oct 7, 2026
- EUDAMED 4fe06463-812e-4eb8-a587-39d3cebfa385 61 fields · synced Oct 7, 2026