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EX3 Stepper

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref 609-004510(k) K871413Ref 644-081

by CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions

Identity

Trade Name
EX3 Stepper EUDAMEDFDA UDI
Generic Name
Prostate brachytherapy system applicator, manual FDA UDI
Device Name
AccuCARE Equipment & Template Grids – Tracked Steppers (EX3) EUDAMED
For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers FDA UDI
For use with Best® Sonalis™ TRT TriView transducers FDA UDI
Model / Reference
609-004 EUDAMEDFDA UDI
644-081 EUDAMEDFDA UDI
Description
For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers FDA UDI
For use with Best® Sonalis™ TRT TriView transducers FDA UDI

Identifiers

Catalog Number
644-081 FDA UDI
609-004 FDA UDI
Primary DI / UDI-DI
00841436101257 EUDAMEDFDA UDI
00841436105972 EUDAMEDFDA UDI
Basic UDI-DI
0841436101TD301CLM EUDAMED
Direct Marketing DI
20841436117931 EUDAMED
510(k) Number
K131161 FDA UDI
FDA Product Code
ITX FDA UDI
JAQ FDA UDI
IWJ FDA UDI
EMDN Code
Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Prostate brachytherapy system applicator, manual FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Class II FDA UDI
Regulation Number
892.1570 FDA UDI
892.5700 FDA UDI
892.5650 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 6.21 Inch FDA UDI
Length — 15.97 Inch FDA UDI

EX3 Stepper by CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
CIVCO Medical Instruments Co., Inc. dba CIVCO and CIVCO Medical Solutions
EUDAMED SRN
US-MF-000008229
FDA Applicant
CIVCO Medical Instruments Co., Inc.
Authorised Representative
MPS Medical Product Service GmbH DE-AR-000005009

Sources (5)

  • EUDAMED 88d9238f-2cb6-4026-8349-e87e1ba723b9 85 fields · synced Oct 6, 2026
  • FDA UDI 09e56a87-9d37-41c5-84c1-bf6650f3e88e 37 fields · synced May 30, 2026
  • FDA UDI 1eceb11f-600d-4135-bd9a-279c5bbd7093 37 fields · synced May 30, 2026
  • EUDAMED 476d0c99-5618-44e6-b072-07d2c518caef 61 fields · synced Jul 23, 2026
  • FDA 510(k) K871413 1 fields · synced May 18, 2026