CHALGREN ENTERPRISES

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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, Needle, Diagnostic Electromyograph (IKT) (7) Electrode, Needle (GXZ) (3)

Premarket Exempt

No Yes

Clear

Chalgren - 00816020020115 Catalog Number : 111-725-24TP

Device Description : Monopolar Needle Electrode, EMG, 25mm x 27g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020122 Catalog Number : 111-737-8TP

Device Description : Monopolar Needle Electrode, EMG, 37mm x 27g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020139 Catalog Number : 111-737-24TP

Device Description : Monopolar Needle Electrode, EMG, 37mm x 27g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020146 Catalog Number : 111-744-24TP

Device Description : Monopolar Needle Electrode, EMG, 44mm x 27g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020153 Catalog Number : 111-837-24TP

Device Description : Monopolar Needle Electrode, EMG, 37mm x 28g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020160 Catalog Number : 111-4100-24TP

Device Description : Monopolar Needle Electrode, EMG, 100mm x 24g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020177 Catalog Number : 111-4125-24TP

Device Description : Monopolar Needle Electrode, EMG, 125mm x 24g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020184 Catalog Number : 112-812-24TP

Device Description : Low Profile Needle Electrode, EEG, 12mm x 28g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020191 Catalog Number : 112-812-48TP

Device Description : Low Profile Needle Electrode, EEG, 12mm x 28g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020207 Catalog Number : 112-812-48BTP

Device Description : Low Profile Needle Electrode, EEG, 12mm x 28g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

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