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Grass® MR Conditional/CT Array Cup Electrodes

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref IFU#045547Model MRSIN1-39;MRSIN2-39;MRSIN3-39;MRSIN1-59;MRSIN2-59;MRSIN3-59;MRARR27-59;MRARR25-39;MRARR25-59;MRARR23-39;MRARR23-59;MRARR30-39;MRARR30-59

by Natus Manufacturing Limited

Identity

Trade Name
Grass® MR Conditional/CT Array Cup Electrodes EUDAMED
Grass® MR Conditional/CT Cup Electrodes FDA UDI
Generic Name
Analytical scalp electrode, single-use FDA UDI
Device Name
Grass® MR Conditional/CT Cup Electrodes EUDAMED
Grass® MR Conditional/CT Cup Electrodes Single, 1-12, 12/pkg, 1M FDA UDI
Model / Reference
MRSIN1-39;MRSIN2-39;MRSIN3-39;MRSIN1-59;MRSIN2-59;MRSIN3-59;MRARR27-59;MRARR25-39;MRARR25-59;MRARR23-39;MRARR23-59;MRARR30-39;MRARR30-59 EUDAMED
IFU#045547 EUDAMED
MRSIN1-39 FDA UDI
Description
Grass® MR Conditional/CT Cup Electrodes Single, 1-12, 12/pkg, 1M FDA UDI

Identifiers

Primary DI / UDI-DI
00382830051156 EUDAMEDFDA UDI
Basic UDI-DI
038283NA00170ED EUDAMED
510(k) Number
K242346 FDA UDI
FDA Product Code
GXY FDA UDI
EMDN Code
N010101 ELECTROMYOGRAPHIC ELECTRODES EUDAMED
GMDN Term
Analytical scalp electrode, single-use FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
882.1320 FDA UDI
Market of Registration
Ireland EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

Yes

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

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Grass® MR Conditional/CT Array Cup Electrodes by Natus Manufacturing Limited — Class I — 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
Natus Manufacturing Limited
EUDAMED SRN
IE-MF-000000799

Sources (3)

  • EUDAMED b5f45454-cd92-492c-b749-fc9c62e69e24 61 fields · synced Jul 9, 2026
  • FDA UDI 93396360-5707-4b64-a0ed-73c845cb6b89 34 fields · synced May 30, 2026
  • FDA 510(k) K242346 1 fields · synced May 18, 2026