Identity
- Trade Name
- Cradle EUDAMEDFDA UDI
- Generic Name
- Prostate brachytherapy system applicator, manual FDA UDI
- Device Name
- AccuCARE Equipment & Template Grids – Tracked Steppers (EX3) EUDAMEDFor use with Terason 8B4S EXII/EX3 Stepper FDA UDI
- Model / Reference
- 683-004 EUDAMEDFDA UDI
- Description
- For use with Terason 8B4S EXII/EX3 Stepper FDA UDI
Identifiers
- Catalog Number
- 683-004 FDA UDI
- Primary DI / UDI-DI
- 00841436111164 EUDAMEDFDA UDI
- Basic UDI-DI
- 0841436101TD301CLM 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
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
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 3.6 Inch FDA UDIWidth — 3.8 Inch FDA UDI
Category: Prostate brachytherapy system applicator, manual
Cradle 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
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 |
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Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (2)
- FDA UDI c2d2f99d-14b2-4103-8c1d-6f75bad2d8cf 38 fields · synced Jul 28, 2026
- EUDAMED c7e4dd18-5152-4959-9842-c6846119e777 61 fields · synced Jul 28, 2026