Identity
- Trade Name
- Needle Guide Starter Kit EUDAMEDFDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Device Name
- General Purpose Guidance – In-Plane, Open Channel (Infiniti plus guide) EUDAMEDReusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides (3), (14 x 147cm) CIV-Flex™ covers (5) for use with FUJIFILM Sonosite HFL50 series transducers FDA UDI
- Model / Reference
- P28773-01 EUDAMEDFDA UDI
- Description
- Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides (3), (14 x 147cm) CIV-Flex™ covers (5) for use with FUJIFILM Sonosite HFL50 series transducers FDA UDI
Identifiers
- Catalog Number
- P28773-01 FDA UDI
- Primary DI / UDI-DI
- 00841436120821 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD101C1ND EUDAMED
- Direct Marketing DI
- 20841436116347 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
Category: Ultrasound imaging system tracking positioner, reusable
Needle Guide Starter Kit 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 Ultrasound imaging system tracking positioner, reusable.
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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 |
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Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (2)
- FDA UDI f0a4a70f-105b-4e52-a145-cfeab85c6e44 37 fields · synced Oct 5, 2026
- EUDAMED 93b0f9e8-2013-4607-b82b-463a7f6b67fa 61 fields · synced Oct 5, 2026