Identity
- Trade Name
- PROcovers™ EUDAMEDFDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
- Device Name
- Intracavity Covers (Latex sterile) EUDAMEDSterile (2.6 x 20cm) cover FDA UDI
- Model / Reference
- 610-076 EUDAMEDFDA UDI
- Description
- Sterile (2.6 x 20cm) cover FDA UDI
Identifiers
- Catalog Number
- 610-076 FDA UDI
- Primary DI / UDI-DI
- 10841436101520 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD201C2NS EUDAMED
- 510(k) Number
- K970515 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
Yes
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 — 2.6 Centimeter FDA UDILength — 20 Centimeter FDA UDI
Category: Body-orifice ultrasound imaging transducer cover, basic
PROcovers™ by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Body-orifice ultrasound imaging transducer cover, basic.
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Cleared under the same submission
K970515 also covers:
- PROcovers™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- PROcovers™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- PROcovers™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- PROcovers™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- PROcovers™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- PROcovers™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- PROcovers™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- PROcovers™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- PROcovers™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- PROcovers™ — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Transducer Cover — CIVCO MEDICAL INSTRUMENTS CO., INC.
- 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 012c939e-1e3b-407c-bf01-d7aab469aa6a 38 fields · synced Jul 20, 2026
- EUDAMED c72cdf88-0dc4-4910-83ab-f2c678f4cd84 61 fields · synced Jul 20, 2026