Identity
- Trade Name
- PROcovers™ FDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, basic FDA UDI
- Device Name
- Sterile (2.6 x 30cm) latex cover for use with BK Medical 2050, 2052, 20R3, 8544, 8554, 8558, 8561, 8644, 8658, 8661, 8815, 8818, 8819, 8848, 8862, 8863, E10C4, E14C4t and N13C5 transducers FDA UDI
- Model / Reference
- UA0005 FDA UDI
- Description
- Sterile (2.6 x 30cm) latex cover for use with BK Medical 2050, 2052, 20R3, 8544, 8554, 8558, 8561, 8644, 8658, 8661, 8815, 8818, 8819, 8848, 8862, 8863, E10C4, E14C4t and N13C5 transducers FDA UDI
Identifiers
- Catalog Number
- UA0005 FDA UDI
- Primary DI / UDI-DI
- 10841436110188 FDA UDI
- 510(k) Number
- K970515 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Body-orifice ultrasound imaging transducer cover, basic 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
Yes
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 — 2.6 Centimeter FDA UDILength — 30 Centimeter FDA UDI
Category: Body-orifice ultrasound imaging transducer cover, basic
PROcovers™ 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
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 (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 86c7691b-7d04-4d03-9c26-3bc3047fb5e9 38 fields · synced Jun 8, 2026