RENISHAW P L C

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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

Alloy, Metal, Base (EJH) (2) Neurological Stereotaxic Instrument (HAW) (1)

Premarket Exempt

No Yes

Clear

Ti DG1 - 05057078000017 Catalog Number :

Device Description : Titanium Powder Ti6-4-GD23

Device Class :

Duns Number: 217226935

Premarket Exempt : Yes

Product Code : EJH

Prescription Use : Yes

Device Count : 1

neuroinspire - 05057078000024 Catalog Number :

Device Description : neuroinspire is a stereotactic software application intended to allow trained cl neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures.

Device Class :

Duns Number: 217226935

Premarket Exempt : No

Product Code : HAW

Prescription Use : Yes

Device Count : 1

Ti DG1 - 05057078000031 Catalog Number :

Device Description : Titanium Powder Ti6-4-GD23

Device Class :

Duns Number: 217226935

Premarket Exempt : Yes

Product Code : EJH

Prescription Use : Yes

Device Count : 1

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