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GammaMed Plus GM+ HDR Ir 192 Brachytherapy Sealed Source
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref GM12000680
Identity
- Trade Name
- GammaMed Plus GM+ HDR Ir 192 Brachytherapy Sealed Source EUDAMEDFDA UDI
- Generic Name
- Remote-afterloading brachytherapy source FDA UDI
- Device Name
- GammaMedplus iX / GammaMedplus 3/24 iX EUDAMED
- Model / Reference
- GM12000680 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM12000680 FDA UDI
- Primary DI / UDI-DI
- 00816389028838 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201002PE EUDAMED
- 510(k) Number
- K030745 FDA UDI
- FDA Product Code
- KXK FDA UDI
- EMDN Code
- Z11010301 BRACHYTHERAPY RADIATION SYSTEMS EUDAMED
- GMDN Term
- Remote-afterloading brachytherapy source FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5730 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
GammaMed Plus GM+ HDR Ir 192 Brachytherapy Sealed Source by Varian Medical Systems, Inc — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 089947500201002PE | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 837b52d9-eca5-45c2-a4d6-175232ca5f4e 61 fields · synced Jul 9, 2026
- FDA UDI 30a9afa1-e06d-434b-808b-7748ef8c002a 34 fields · synced May 30, 2026