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GE Ultra-Pro II Biopsy Starter Kit
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref H40482LP
Identity
- Trade Name
- GE Ultra-Pro II Biopsy Starter Kit EUDAMEDFDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Device Name
- General Purpose Guidance – In-Plane, Fixed Angle (Ultra-Pro II guide) EUDAMEDReusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5) and (8.9 × 91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare 4Vc transducers FDA UDI
- Model / Reference
- H40482LP EUDAMEDFDA UDI
- Description
- Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5) and (8.9 × 91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare 4Vc transducers FDA UDI
Identifiers
- Catalog Number
- H40482LP FDA UDI
- Primary DI / UDI-DI
- 00841436110525 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD101A3NB EUDAMED
- Direct Marketing DI
- 20841436116361 EUDAMED
- 510(k) Number
- K093713 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Ultrasound imaging system tracking positioner, reusable 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 — 2.1 Inch FDA UDIWidth — 1.5 Inch FDA UDI
Category: Ultrasound imaging system tracking positioner, reusable
GE Ultra-Pro II Biopsy Starter Kit by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Ultrasound imaging system tracking positioner, reusable.
- BIOPSY ADAPTOR — Canon Medical Systems Corporation · Class II
- Multi Angle Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- NGB-025 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Reusable Biopsy Bracket — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Reusable Multi Angle Biospy Bracket — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Reusable Biopsy Bracket — PROTEK MEDICAL PRODUCTS, INC. · Class II
Cleared under the same submission
K093713 also covers:
- AccuSITE Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- AccuSITE™ Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Bracket — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Brackt — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (2)
- FDA UDI e1a69cbe-b6cb-4bb6-8689-35135ebe4c56 38 fields · synced Jun 18, 2026
- EUDAMED fe682004-2b58-44cf-87f5-3f42cf6ce021 61 fields · synced Jun 18, 2026