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Intrauterine tandem for 90° ring, 30 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11011320Model Ring Applicator Set 90°Ref GM11010940
Identity
- Trade Name
- Intrauterine tandem for 90° ring, 30 mm EUDAMEDIntrauterine tandem for 90° ring, 30 mm, with 7 needles holes EUDAMEDIntrauterine tandem for 90 degree ring, 30mm FDA UDIIntrauterine tandem for 90 degree ring, 30 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° EUDAMEDGM11011320 EUDAMEDFDA UDIGM11010940 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11011320 FDA UDIGM11010940 FDA UDI
- Primary DI / UDI-DI
- 00816389026063 EUDAMEDFDA UDI00816389025707 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 — 30 Millimeter FDA UDI
Intrauterine tandem for 90° ring, 30 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 91c8b21c-1ce5-4131-9380-69e29c102149 61 fields · synced Jul 11, 2026
- EUDAMED cae9b436-9642-40a8-80f1-9bf3424578c8 61 fields · synced May 16, 2026
- FDA UDI 990a796e-4ece-4385-a988-ad40350c0968 35 fields · synced May 30, 2026
- FDA UDI ddc31f72-7639-4b63-bc98-6b8d46bd86e6 35 fields · synced May 30, 2026
- EUDAMED 48c0d398-8838-4b50-9f38-f77b83a249a7 61 fields · synced Jul 10, 2026