Multi-Purpose Workstation™ Stepper

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 620-094Ref 642-334Ref 620-113Ref 620-117Ref 676-121Ref 642-510

by Civco Medical Instruments Co., Inc.

Identity

Trade Name: Multi-Purpose Workstation™ Stepper EUDAMEDFDA UDI
Generic Name: Prostate brachytherapy system applicator, manual FDA UDI
Device Name: AccuCARE Equipment & Template Grids – (Multi-purpose workstation steppers) EUDAMED
For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers FDA UDI
For use with BK Medical 8808e, 8818 and E14C4t transducers FDA UDI
For use with BK Medical 8848 and E14CL4b transducers FDA UDI
For use with GE Healthcare ERB transducers FDA UDI
For use with Siemens Endo-PII transducers FDA UDI
For use with GE E7C8L trasducers FDA UDI
For use with BK Medical 8658 (8558) and 8808 transducers FDA UDI
Model / Reference: 620-113 EUDAMEDFDA UDI
620-117 EUDAMEDFDA UDI
642-334 EUDAMEDFDA UDI
676-121 EUDAMEDFDA UDI
642-510 EUDAMEDFDA UDI
620-094 EUDAMEDFDA UDI
644-066 FDA UDI
Description: For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers FDA UDI
For use with BK Medical 8808e, 8818 and E14C4t transducers FDA UDI
For use with BK Medical 8848 and E14CL4b transducers FDA UDI
For use with GE Healthcare ERB transducers FDA UDI
For use with Siemens Endo-PII transducers FDA UDI
For use with GE E7C8L trasducers FDA UDI
For use with BK Medical 8658 (8558) and 8808 transducers FDA UDI

Identifiers

Catalog Number: 644-066 FDA UDI
620-113 FDA UDI
620-117 FDA UDI
642-334 FDA UDI
676-121 FDA UDI
642-510 FDA UDI
620-094 FDA UDI
Primary DI / UDI-DI: 00841436105354 EUDAMEDFDA UDI
00841436105378 EUDAMEDFDA UDI
00841436105781 EUDAMEDFDA UDI
00841436107280 EUDAMEDFDA UDI
00841436121149 EUDAMEDFDA UDI
00841436105279 EUDAMEDFDA UDI
00841436105842 FDA UDI
Basic UDI-DI: 0841436101TD301B2P2 EUDAMED
Direct Marketing DI: 20841436117979 EUDAMED
20841436118006 EUDAMED
20841436117986 EUDAMED
20841436117993 EUDAMED
20841436118020 EUDAMED
510(k) Number: K131161 FDA UDI
FDA Product Code: JAQ FDA UDI
IWJ FDA UDI
ITX 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: 892.5700 FDA UDI
892.5650 FDA UDI
892.1570 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDIFDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDIFDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 24.3 Centimeter FDA UDI
Width — 12.2 Centimeter FDA UDI
Length — 39.2 Centimeter FDA UDI
Length — 9.58 Inch FDA UDI
Height — 5.78 Inch FDA UDI

Category: Prostate brachytherapy system applicator, manual

Multi-Purpose Workstation™ Stepper by Civco Medical Instruments Co., Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED

Small Prostate Template — LIBERTY MEDICAL INC · Class I
Small Prostate Brachytherapy Kit — LIBERTY MEDICAL INC · Class I
Small Prostate Brachytherapy Kit — LIBERTY MEDICAL INC · Class I
Small Prostate Template — LIBERTY MEDICAL INC · Class I
Small Prostate Template — LIBERTY MEDICAL INC · Class I
Large Prostate Template — LIBERTY MEDICAL INC · Class I
Medium Prostate Brachytherapy Kit — LIBERTY MEDICAL INC · Class I
Medium Prostate Brachytherapy Kit-metal hub — LIBERTY MEDICAL INC · Class I

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 (13)

FDA UDI a22d9ff5-7b27-4178-bbfc-8e68def67d6b 37 fields · synced Jul 31, 2026
FDA UDI 4a753b76-c6f0-4764-8bdf-95744377bce3 37 fields · synced May 29, 2026
FDA UDI 5c2f4a7d-2259-49e8-a1bc-d03e17d2e7da 37 fields · synced May 29, 2026
FDA UDI d538d259-5501-460a-a2c6-44984b461fcc 37 fields · synced May 29, 2026
FDA UDI 9c1b15f0-94d9-4921-a55c-30d43c360863 37 fields · synced May 30, 2026
FDA UDI 53c275e6-e07f-4cbf-95d9-b08fa3cd196c 36 fields · synced May 30, 2026
FDA UDI 6eddac34-f7bf-4e32-88cb-6041b7b9c167 37 fields · synced May 30, 2026
EUDAMED dbb34ede-f2e9-4ee0-a5cb-61d66835b1c0 61 fields · synced Jun 20, 2026
EUDAMED ced66d66-5ef6-4120-8b2e-3545f18cba77 61 fields · synced Jul 13, 2026
EUDAMED c0aaf3b4-2e92-492f-a24e-e50dd39e2233 61 fields · synced Jul 15, 2026
EUDAMED 9f685702-d667-4073-943c-498f8923732f 61 fields · synced Jul 16, 2026
EUDAMED 7f9f7567-5ef7-4bec-b3cb-ba10202be5b4 61 fields · synced Jul 19, 2026
EUDAMED b6a86ca4-a9e7-4bb6-b853-92184659b17b 61 fields · synced Jul 31, 2026

Multi-Purpose Workstation™ Stepper

Identity

Identifiers

Classification

Clinical & Handling

Dimensions & Sizes

Similar devices

Cleared under the same submission

Authorization Coverage (2 countries)

Regulatory Authorizations

Manufacturer

Sources (13)