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Guiding tube 90° ring with interstitial cervical stop for central needle insert…
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref GM11010970
Identity
- Trade Name
- Guiding tube 90° ring with interstitial cervical stop for central needle insertion EUDAMEDGuiding tube 90 degrees ring with interstitial cervical stop FDA UDI
- Generic Name
- Cervical/intrauterine brachytherapy system applicator, remote-afterloading FDA UDI
- Device Name
- 3D Interstitial Ring Applicator Set 90° EUDAMEDfor central needle insertion FDA UDI
- Model / Reference
- GM11010970 EUDAMEDFDA UDI
- Description
- for central needle insertion FDA UDI
Identifiers
- Catalog Number
- GM11010970 FDA UDI
- Primary DI / UDI-DI
- 00816389025738 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201135Q2 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
- Angle — 90 degree FDA UDI
Guiding tube 90° ring with interstitial cervical stop for central needle insert… by Varian Medical Systems, Inc — Class IIa — FDA_510K, MDR — listed in…
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160815 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K073133 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 089947500201135Q2 | Class IIa | Active |
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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 c85e888a-3254-4efe-9265-ab1883e84692 61 fields · synced Jul 8, 2026
- FDA UDI da9f4a3a-d54c-4eff-aa8b-9ce0091d4771 36 fields · synced May 30, 2026
- FDA 510(k) K160815 1 fields · synced May 18, 2026