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Intrauterine tandem for 90° ring, 70 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11011360Model Ring Applicator Set 90°Ref GM11010960
Identity
- Trade Name
- Intrauterine tandem for 90° ring, 70 mm EUDAMEDIntrauterine tandem for 90° ring, 70 mm, with 7 needles holes EUDAMEDIntrauterine tandem for 90 degree ring, 70mm FDA UDIIntrauterine tandem for 90 degree ring, 70 mm, with 7 needles holes FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- 3D Interstitial Ring Applicator Set 90° EUDAMED
- Model / Reference
- Ring Applicator Set 90° EUDAMEDGM11011360 EUDAMEDFDA UDIGM11010960 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11011360 FDA UDIGM11010960 FDA UDI
- Primary DI / UDI-DI
- 00816389026100 EUDAMEDFDA UDI00816389025721 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201026PU EUDAMED089947500201135Q2 EUDAMED
- 510(k) Number
- K150839 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Cervical/intrauterine 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Length — 70 Millimeter FDA UDI
Intrauterine tandem for 90° ring, 70 mm by Varian Medical Systems, Inc — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 089947500201026PU | 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 (5)
- EUDAMED dcfd0088-cf5e-439c-a9f1-f4295eff4963 61 fields · synced Jul 19, 2026
- EUDAMED c181036d-46dc-4dcf-9a56-943c57395e3a 61 fields · synced May 18, 2026
- FDA UDI fa5063a0-a4a2-4162-9663-e6de2b5506c1 35 fields · synced May 29, 2026
- FDA UDI 533c3cd4-f4d0-4056-a907-5b77f8eecc62 35 fields · synced May 30, 2026
- EUDAMED 25558d68-f9f9-40eb-9904-9567cbdb9c5c 61 fields · synced Jul 12, 2026