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Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin (GM110103…

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref GM11014700

by Varian Medical Systems, Inc.

Identity

Trade Name
Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin (GM11010390) EUDAMED
Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin FDA UDI
Generic Name
Brachytherapy injection needle FDA UDI
Device Name
Interstitial Plastic Needles EUDAMED
Model / Reference
GM11014700 EUDAMEDFDA UDI

Identifiers

Catalog Number
GM11014700 FDA UDI
Primary DI / UDI-DI
00810563022025 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 EUDAMED
Class 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin (GM110103… by Varian Medical Systems, Inc — Class IIa — FDA_510K, MDR — listed in…

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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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 65f80b8d-9a98-47e5-9817-d5c405846301 61 fields · synced Jul 14, 2026
  • FDA UDI 53ea3669-25f4-4dc6-abd0-4a7eb6cceec4 34 fields · synced May 30, 2026
  • FDA 510(k) K120341 1 fields · synced May 18, 2026