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Crook Prostate Template for 2.0 mm needles, B-K labelling, including locking co…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11012230
Identity
- Trade Name
- Crook Prostate Template for 2.0 mm needles, B-K labelling, including locking collets (pack of 25) and needle collet wrench EUDAMEDCrook Prostate Template for 2.0 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
- GM11012230 EUDAMEDFDA UDI
- Description
- B-K labelling, including locking collets (pack of 25) and needle collet wrench FDA UDI
Identifiers
- Catalog Number
- GM11012230 FDA UDI
- Primary DI / UDI-DI
- 00816389020245 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 2.0 mm needles, B-K labelling, including locking co… 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 759192fe-db57-49b2-a3ae-8633c7defb7e 61 fields · synced Jun 18, 2026
- FDA UDI d5e06b1d-f498-41dd-82e8-a9ea7fe4e947 35 fields · synced May 30, 2026