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Kelowna GYN Template for 2.0 mm needles, including locking collets (pack of 25)…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11012200
Identity
- Trade Name
- Kelowna GYN Template for 2.0 mm needles, including locking collets (pack of 25) and needle collet wrench EUDAMEDKelowna GYN 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 EUDAMEDIncluding locking collets (pack of 25) and needle collet wrench FDA UDI
- Model / Reference
- GM11012200 EUDAMEDFDA UDI
- Description
- Including locking collets (pack of 25) and needle collet wrench FDA UDI
Identifiers
- Catalog Number
- GM11012200 FDA UDI
- Primary DI / UDI-DI
- 00816389020214 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
Kelowna GYN Template for 2.0 mm needles, including locking collets (pack of 25)… 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 be879791-915e-4e1c-95a8-85bab73f3881 61 fields · synced Jul 20, 2026
- FDA UDI 5609a48a-5e2f-469e-a1c9-71a17e8755cf 35 fields · synced May 30, 2026