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3D-FSD interstitial ovoid pair for 30 mm spread, with 8 needle guide holes each…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11010730
Identity
- Trade Name
- 3D-FSD interstitial ovoid pair for 30 mm spread, with 8 needle guide holes each ovoid EUDAMED3D FSD interstitial ovoid pair for 30 mm spread FDA UDI3D-FSD interstitial ovoid pair for 30mm spread with 8 needle guide holes/ovoid FDA UDI
- Generic Name
- Vaginal brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- Interstitial ovoids and needle collector pair EUDAMED3D FSD interstitial ovoid pair for 30 mm spread, with 8 needle guide holes each ovoid FDA UDIFor Titanium Fletcher-style Applicator Set Defined Geometry FDA UDI
- Model / Reference
- GM11010730 EUDAMEDFDA UDI
- Description
- 3D FSD interstitial ovoid pair for 30 mm spread, with 8 needle guide holes each ovoid FDA UDIFor Titanium Fletcher-style Applicator Set Defined Geometry FDA UDI
Identifiers
- Catalog Number
- GM11010730 FDA UDI
- Primary DI / UDI-DI
- 00810563022544 EUDAMEDFDA UDI00816389025592 FDA UDI
- Basic UDI-DI
- 089947500201204PU EUDAMED
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Vaginal 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 UDIFDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
3D-FSD interstitial ovoid pair for 30 mm spread, with 8 needle guide holes each… 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 | 089947500201204PU | 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 (3)
- EUDAMED 04f47f03-eb6f-434c-acc8-2193b2b7f73c 61 fields · synced Jun 18, 2026
- FDA UDI 70d32964-5849-4e25-b7f6-72e313e62546 35 fields · synced May 30, 2026
- FDA UDI 9ca5aa53-2da6-489c-8f2a-a7598e906564 35 fields · synced May 30, 2026