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Intrauterine tandem for 45° ring, 60 mmt
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11011010Model Ring Applicator Set 45°Ref GM11010490
Identity
- Trade Name
- Intrauterine tandem for 45° ring, 60 mmt EUDAMEDIntrauterine tandem for 45° ring, 60 mm EUDAMEDRing Applicator Set 45° EUDAMEDRing Applicator Set 45 degree FDA UDIIntrauterine tandem for 45 degrees ring, 60 mm FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- Ring Applicator Set 45° EUDAMEDGM11011010 EUDAMEDFDA UDIGM11010490 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11010490 FDA UDIGM11011010 FDA UDI
- Primary DI / UDI-DI
- 00816389025776 EUDAMEDFDA UDI00816389025370 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201046Q2 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 45° ring, 60 mmt 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 | 089947500201046Q2 | 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 72d0481a-cc4d-445a-8452-766d304b46b7 61 fields · synced Jul 15, 2026
- FDA UDI 081940d8-2ab7-4fbf-9321-1fffcde70583 34 fields · synced May 24, 2026
- FDA UDI a7b4a334-4bbf-4a33-86de-d2f8a32b2bca 35 fields · synced May 25, 2026
- EUDAMED a46c85d2-298f-4364-9866-66e939b78e02 61 fields · synced Jun 19, 2026
- EUDAMED 9e0944b5-a7b4-4316-ae83-60de7c567e05 61 fields · synced Jul 15, 2026