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Stainless steel needle 320mm, 18 gauge, trocar point
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref GM11009580
Identity
- Trade Name
- Stainless steel needle 320mm, 18 gauge, trocar point EUDAMEDFDA UDI
- Generic Name
- Brachytherapy injection needle FDA UDI
- Device Name
- Stainless Steel Needles 17G & 18G EUDAMED
- Model / Reference
- GM11009580 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- GM11009580 FDA UDI
- Primary DI / UDI-DI
- 00816389029286 EUDAMEDFDA UDI
- Basic UDI-DI
- 089947500201003PG EUDAMED
- 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
MR Unsafe FDA UDI
Stainless steel needle 320mm, 18 gauge, trocar point 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 | 089947500201003PG | 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 37167a24-b45d-4858-bb0e-036f66768529 61 fields · synced Jul 11, 2026
- FDA UDI 41679c9e-bd17-4b1e-8247-7e9948072233 33 fields · synced May 30, 2026