Identity
- Trade Name
- Brachytherapy Kit 3 FDA UDI
- Generic Name
- Body-orifice ultrasound imaging transducer cover, image-enhancement FDA UDI
- Device Name
- Sterile (81.3 x 91.4cm) polyethylene drape (2), non-sterile (2 x 14cm) endocavity balloon (2) for use with AccuCARE Positioning and Stabilizing equipment FDA UDI
- Model / Reference
- 610-1295-5 FDA UDI
- Description
- Sterile (81.3 x 91.4cm) polyethylene drape (2), non-sterile (2 x 14cm) endocavity balloon (2) for use with AccuCARE Positioning and Stabilizing equipment FDA UDI
Identifiers
- Catalog Number
- 610-1295-5 FDA UDI
- Primary DI / UDI-DI
- 00841436103053 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Body-orifice ultrasound imaging transducer cover, image-enhancement 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
No
FDA UDI
Single Use
No
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
Dimensions & Sizes
- Size
- Length — 7.5 Inch FDA UDILumen/Inner Diameter — 0.83 Inch FDA UDI
Category: Body-orifice ultrasound imaging transducer cover, image-enhancement
Brachytherapy Kit 3 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
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- 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.
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K992152 also covers:
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 c84b710c-0e35-4fa0-9a10-44c5656274ed 38 fields · synced Jun 8, 2026