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Intrauterine tandem for 90° ring, 60 mm, with 7 needles holes
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11010920Ref GM11011350Model Ring Applicator Set 90°
Identity
- Trade Name
- Intrauterine tandem for 90° ring, 60 mm, with 7 needles holes EUDAMEDIntrauterine tandem for 90° ring, 60 mm EUDAMEDIntrauterine tandem for 90 degrees ring, 60 mm FDA UDIIntrauterine tandem for 90 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 90° EUDAMED
- Model / Reference
- GM11010920 EUDAMEDFDA UDIRing Applicator Set 90° EUDAMEDGM11011350 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11011350 FDA UDIGM11010920 FDA UDI
- Primary DI / UDI-DI
- 00816389025684 EUDAMEDFDA UDI00816389026094 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201135Q2 EUDAMED089947500201026PU 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 90° ring, 60 mm, with 7 needles holes by Varian Medical Systems, Inc — Class IIa — 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 | 089947500201135Q2 | 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 55f1894d-b080-4cbe-a366-01ef99dcd86b 61 fields · synced Oct 6, 2026
- EUDAMED 6675c2c4-239b-4fc4-b950-7e64a6e29c0d 61 fields · synced May 19, 2026
- FDA UDI 47cee13d-e081-4c02-87dd-65927c15061f 35 fields · synced May 30, 2026
- FDA UDI cd57d7d0-7a7a-4930-8fa2-644c9ddd456d 35 fields · synced May 30, 2026
- EUDAMED fb4a9bfb-f7c5-4e49-8ee7-0574f74779fb 61 fields · synced Jul 10, 2026