Identity
- Trade Name
- CIV-Flex™ Transducer Cover FDA UDI
- Generic Name
- Body-surface ultrasound imaging transducer cover FDA UDI
- Device Name
- Sterile (7.4 tapered to 9.5 x 30.5cm) telescopically-folded transducer cover FDA UDI
- Model / Reference
- 610-1305 FDA UDI
- Description
- Sterile (7.4 tapered to 9.5 x 30.5cm) telescopically-folded transducer cover FDA UDI
Identifiers
- Catalog Number
- 610-1305 FDA UDI
- Primary DI / UDI-DI
- 10841436103111 FDA UDI
- 510(k) Number
- K970513 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Body-surface ultrasound imaging transducer cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
- Width — 9.5 Centimeter FDA UDILength — 30.5 Centimeter FDA UDI
Category: Body-surface ultrasound imaging transducer cover
CIV-Flex™ Transducer Cover by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI fa3c90cc-5881-415c-94d5-335ff7dbbdf7 38 fields · synced Jun 8, 2026