Identity
- Trade Name
- Cradle for Classic Stepper EUDAMEDFDA UDI
- Generic Name
- Prostate brachytherapy system applicator, manual FDA UDI
- Device Name
- AccuCARE Equipment & Template Grids – (Classic Steppers) EUDAMEDFor use with Hitachi Aloka Medical UST-672-5/7.5 Classic Stepper FDA UDIFor use with Hitachi Aloka Medical C41L47RP and EUP-U533 Classic Stepper FDA UDI
- Model / Reference
- 644-087 EUDAMEDFDA UDI644-086 FDA UDI
- Description
- For use with Hitachi Aloka Medical UST-672-5/7.5 Classic Stepper FDA UDIFor use with Hitachi Aloka Medical C41L47RP and EUP-U533 Classic Stepper FDA UDI
Identifiers
- Catalog Number
- 644-086 FDA UDI644-087 FDA UDI
- Primary DI / UDI-DI
- 00841436110853 EUDAMEDFDA UDI00841436110846 FDA UDI
- Basic UDI-DI
- 0841436101TD301B1NY EUDAMED
- 510(k) Number
- K131161 FDA UDI
- FDA Product Code
- ITX FDA UDIIWJ FDA UDIJAQ 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 EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.5650 FDA UDI892.5700 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 6.3 Centimeter FDA UDILength — 13.1 Centimeter FDA UDIWidth — 7.3 Centimeter FDA UDI
Category: Prostate brachytherapy system applicator, manual
Cradle for Classic Stepper 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 Prostate brachytherapy system applicator, manual.
- 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
Cleared under the same submission
K131161 also covers:
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Classic Stepper — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Classic Stepper — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Classic Stepper — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Classic Stepper — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Classic Stepper — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Classic Stepper — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Classic Stepper — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Cradle — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Cradle — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Cradle — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Cradle — 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 (3)
- FDA UDI c24e40ae-e5dd-4fae-8934-e4c8680e254a 38 fields · synced Jul 9, 2026
- FDA UDI 33e211e6-e48e-42b1-a42f-ec7bfacc14c8 38 fields · synced May 30, 2026
- EUDAMED 3e97c9dd-bcf4-4147-a3bc-e364e78de1b4 61 fields · synced Jul 9, 2026