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) (9) Electrode, Cutaneous (GXY) (1)

Premarket Exempt

No Yes

Clear

Chalgren - 00816020020009 Catalog Number : 110-725

Device Description : Detachable 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 - 00816020020016 Catalog Number : 110-637

Device Description : Detachable Monopolar Needle Electrode, EMG, 37mm x 26g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020023 Catalog Number : 444-10G-48TP

Device Description : Reusable Disc Electrodes, EEG, 10mm Gold Plated Discs, 48 inch Coated Leadwire ( Reusable Disc Electrodes, EEG, 10mm Gold Plated Discs, 48 inch Coated Leadwire (Assorted Colors)

Device Class : 2

Duns Number: 085932630

Premarket Exempt : No

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020030 Catalog Number : 110-650

Device Description : Detachable Monopolar Needle Electrode, EMG, 50mm x 26ga

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020047 Catalog Number : 110-725

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

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020054 Catalog Number : 110-737

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

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020061 Catalog Number : 110-744

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

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020085 Catalog Number : 111-575-24TP

Device Description : Monopolar Needle Electrode, EMG, 75mm x 25g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020092 Catalog Number : 111-637-24TP

Device Description : Monopolar Needle Electrode, EMG, 37mm x 26g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

Chalgren - 00816020020108 Catalog Number : 111-650-24TP

Device Description : Monopolar Needle Electrode, EMG, 50mm x 26g

Device Class :

Duns Number: 085932630

Premarket Exempt : No

Product Code : IKT

Prescription Use : Yes

Device Count : 1

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