Identity
- Trade Name
- GE Ultra-Pro II 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 (14 × 91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare eM6C-G2 transducers FDA UDI
- Model / Reference
- H48701MP EUDAMEDFDA UDI
- Description
- Reusable non-sterile multi-angle bracket with Ultra-Pro II™ needle guides (5) and (14 × 91.5cm) CIV-Flex™ covers (5) for use with GE Healthcare eM6C-G2 transducers FDA UDI
Identifiers
- Catalog Number
- H48701MP FDA UDI
- Primary DI / UDI-DI
- 00841436110716 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD101A3NB EUDAMED
- Direct Marketing DI
- 20841436116323 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
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
- Length — 3.7 Inch FDA UDIWidth — 2.1 Inch FDA UDI
Category: Ultrasound imaging system tracking positioner, reusable
GE Ultra-Pro II Starter Kit by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (2)
- FDA UDI 54dfa50d-f3d9-45c3-b232-588b1333a33b 38 fields · synced Oct 6, 2026
- EUDAMED e20d9481-88e3-4add-a902-a3d6f5a27ac4 61 fields · synced Jul 26, 2026