Identity
- Trade Name
- Intuit Roll Transducer Cover EUDAMEDFDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- General Purpose and Intraoperative Covers (Intuit rolled sterile) EUDAMEDSterile (14 x 91.5cm) rolled CIV-Flex™ cover FDA UDI
- Model / Reference
- 610-1311 EUDAMED610-1311, 610-1311-5 FDA UDI
- Description
- Sterile (14 x 91.5cm) rolled CIV-Flex™ cover FDA UDI
Identifiers
- Catalog Number
- 610-1311, 610-1311-5 FDA UDI
- Primary DI / UDI-DI
- 10841436111017 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD201A5NS 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
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 — 36 Inch FDA UDIWidth — 5.5 Inch FDA UDI
Category: Body-surface ultrasound imaging transducer cover
Intuit Roll 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 d58b3d71-4575-4407-8ed3-29f4eea1dce8 38 fields · synced Oct 6, 2026
- EUDAMED 2efdac5d-85bb-40c5-b1e5-80f272588858 61 fields · synced Jul 17, 2026