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Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin (GM110104…
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11014720
Identity
- Trade Name
- Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin (GM11010470) EUDAMEDPlastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin FDA UDI
- Generic Name
- Brachytherapy injection needle FDA UDI
- Device Name
- Interstitial Plastic Needles EUDAMED
- Model / Reference
- GM11014720 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11014720 FDA UDI
- Primary DI / UDI-DI
- 00810563021974 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201048Q6 EUDAMED
- 510(k) Number
- K141624 FDA UDI
- FDA Product Code
- JAQ FDA UDI
- EMDN Code
- Z11010380 BRACHYTHERAPY RADIATION SYSTEMS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Brachytherapy injection needle 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Plastic needle MR safe, 2.0 mm diameter x 320 mm length, with mandrin (GM110104… by Varian Medical Systems, Inc — Class IIa — MDR, FDA UDI — listed in…
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 | 089947500201048Q6 | 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 (2)
- EUDAMED 6eeb61f2-442e-4cda-839b-262b171a9dc4 61 fields · synced Jul 9, 2026
- FDA UDI 268fb39f-242a-42f7-bc78-c61867905351 34 fields · synced May 30, 2026