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Intrauterine tandem for 60° ring, 60 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11011250Model Ring Applicator Set 60°Ref GM11010670
Identity
- Trade Name
- Intrauterine tandem for 60° ring, 60 mm EUDAMEDIntrauterine tandem for 60° ring, 60 mm, with 7 needles hole EUDAMEDIntrauterine tandem for 60 degrees ring, 60 mm FDA UDIIntrauterine tandem for 60 degrees ring, 60 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 60° EUDAMED
- Model / Reference
- Ring Applicator Set 60° EUDAMEDGM11011250 EUDAMEDFDA UDIGM11010670 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11011250 FDA UDIGM11010670 FDA UDI
- Primary DI / UDI-DI
- 00816389026001 EUDAMEDFDA UDI00816389025530 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201027PW EUDAMED089947500201134PY 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 — 60 Millimeter FDA UDI
Intrauterine tandem for 60° ring, 60 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 | 089947500201027PW | 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 1eb903ef-87be-4a2c-a236-c4046ee3023f 61 fields · synced Jul 10, 2026
- EUDAMED 23d6e6ee-39f9-4ea9-92d0-3095f0e1947a 61 fields · synced May 18, 2026
- FDA UDI 72d2e64d-82c2-4dd8-84ea-3019e7634e3d 35 fields · synced May 30, 2026
- FDA UDI 8629e96b-2a7a-4a23-8115-57c8ce87b051 35 fields · synced May 30, 2026
- EUDAMED a1e19e2c-c0b2-4440-9cec-d3c0b870d045 61 fields · synced Jul 10, 2026