XLTEK

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Electrode, Cutaneous (GXY) (4) Camera, Ophthalmic, Ac-Powered (HKI) (1)

Premarket Exempt

No Yes

Clear

Natus - 00382830059268 Catalog Number :

Device Description : External Battery Pack with packaging

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830059275 Catalog Number :

Device Description : Natus Base Unit to Nicolet Cortical Stim Cable

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830059299 Catalog Number :

Device Description : External Battery Pack Power Supply

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830059305 Catalog Number :

Device Description : Quantum Breakout Roll Stand

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Natus - 00382830060110 Catalog Number :

Device Description : RetCam FA Upgrade Kit

Device Class : 2

Duns Number: 245258280

Premarket Exempt : No

Product Code : HKI

Prescription Use : Yes

Device Count : 1

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