Identity
- Trade Name
- Cradle FDA UDI
- Generic Name
- Prostate brachytherapy system applicator, manual FDA UDI
- Device Name
- For use with Hitachi Aloka Medical C41L47RP and EUP-U533 EXII/EX3 Steppers FDA UDI
- Model / Reference
- 644-089 FDA UDI
- Description
- For use with Hitachi Aloka Medical C41L47RP and EUP-U533 EXII/EX3 Steppers FDA UDI
Identifiers
- Catalog Number
- 644-089 FDA UDI
- Primary DI / UDI-DI
- 00841436111560 FDA UDI
- 510(k) Number
- K131161 FDA UDI
- FDA Product Code
- JAQ FDA UDIITX FDA UDIIWJ FDA UDI
- GMDN Term
- Prostate brachytherapy system applicator, manual FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5700 FDA UDI892.1570 FDA UDI892.5650 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
- Length — 9.9 Centimeter FDA UDIWidth — 9.4 Centimeter FDA UDI
Category: Prostate brachytherapy system applicator, manual
Cradle by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI f11e9120-e21c-428b-9cd4-24c02b981532 38 fields · synced Jun 8, 2026