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Temperature Sensor Probe, 18G x 20cm

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref ABL-18TP20

by Varian Medical Systems, Inc.

Identity

Trade Name
Temperature Sensor Probe, 18G x 20cm EUDAMEDFDA UDI
Generic Name
Patient monitoring system module, temperature FDA UDI
Device Name
Temperature Sensor Probe EUDAMED
Ablation accessory: disposable temperature probe, 18G/20cm Probe QTY 1 FDA UDI
Model / Reference
ABL-18TP20 EUDAMEDFDA UDI
Description
Ablation accessory: disposable temperature probe, 18G/20cm Probe QTY 1 FDA UDI

Identifiers

Primary DI / UDI-DI
00810563022322 EUDAMEDFDA UDI
Basic UDI-DI
089947500200147Q2 EUDAMED
510(k) Number
K240784 FDA UDI
FDA Product Code
NEY FDA UDI
EMDN Code
Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Patient monitoring system module, temperature FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
878.4400 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Temperature Sensor Probe, 18G x 20cm by Varian Medical Systems, Inc — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

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-000007453
Authorised Representative
Siemens Healthineers Nederland B.V. NL-AR-000000803

Sources (3)

  • EUDAMED 5e99f69e-6ca4-4de4-9d6d-98b76c462fa2 61 fields · synced Jul 9, 2026
  • FDA UDI 478bb7dd-d1c0-40f7-91b2-dbfc458e0e62 34 fields · synced May 30, 2026
  • FDA 510(k) K240784 1 fields · synced May 18, 2026