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Crook Prostate Template for 17 gauge (1.47 mm) needles, B-K labelling, includin…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11012240
Identity
- Trade Name
- Crook Prostate Template for 17 gauge (1.47 mm) needles, B-K labelling, including locking collets (pack of 25) and needle collet wrench EUDAMEDCrook Prostate Template for 17 gauge (1.47 mm) needles FDA UDI
- Generic Name
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Kelowna GYN and Crook Prostate Templates EUDAMEDB-K labelling, including locking collets (pack of 25) and needle collet wrench FDA UDI
- Model / Reference
- GM11012240 EUDAMEDFDA UDI
- Description
- B-K labelling, including locking collets (pack of 25) and needle collet wrench FDA UDI
Identifiers
- Catalog Number
- GM11012240 FDA UDI
- Primary DI / UDI-DI
- 00816389020252 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201144Q3 EUDAMED
- 510(k) Number
- K232949 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- General-purpose brachytherapy system applicator, remote-afterloading FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5700 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Moist Heat or Steam Sterilization FDA UDI
Crook Prostate Template for 17 gauge (1.47 mm) needles, B-K labelling, includin… by Varian Medical Systems, Inc — Class IIa — MDR, FDA UDI — listed in…
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 089947500201144Q3 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Varian Medical Systems, Inc.
- EUDAMED SRN
- US-MF-000001784
- Authorised Representative
- Siemens Healthineers Nederland B.V. NL-AR-000000803
Sources (2)
- EUDAMED 26e23cb6-0fda-492f-ad20-08cca374f1b2 61 fields · synced Jul 30, 2026
- FDA UDI f6e21856-5add-45a0-8d71-da829a438212 35 fields · synced May 30, 2026