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Intrauterine tandem for 45° ring, 40 mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11010990Model Ring Applicator Set 45°
Identity
- Trade Name
- Intrauterine tandem for 45° ring, 40 mm EUDAMEDIntrauterine tandem for 45 degrees ring, 40 mm FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Model / Reference
- Ring Applicator Set 45° EUDAMEDGM11010990 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11010990 FDA UDI
- Primary DI / UDI-DI
- 00816389025752 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 — 40 Millimeter FDA UDI
Intrauterine tandem for 45° ring, 40 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 | 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 (3)
- EUDAMED a0fd12a8-5fff-42ee-ae52-b65d75fcedfc 61 fields · synced Jul 17, 2026
- FDA UDI b00a7624-26fd-4aed-b6e3-5727fd5f242c 35 fields · synced May 30, 2026
- EUDAMED e4f1dd1a-c30a-4e2f-9e5f-c4ba789ba2c8 61 fields · synced Jul 17, 2026