THERAGEN, LLC

Address:25003 Pitkin Road Suite D800,Spring,TX,77386,US

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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

Stimulator, Bone Growth, Non-Invasive (LOF) (6)

Premarket Exempt

Clear

ActaStim-S - 00850372007219 Catalog Number : 4101-0001

Device Description : ActaStim-S Spine Fusion Stimulator - Electrodes, Type 2

Device Class : 3

Duns Number: 080028759

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

ActaStim-S - 00850372007226 Catalog Number : 1101-0003

Device Description : ActStim-S Spine Fusion Stimulator Charger

Device Class : 3

Duns Number: 080028759

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

ActaStim-S - 00850372007233 Catalog Number : 1101-0016

Device Description : ActaStim-S Spine Fusion Stimulator - Dock, Battery Charger

Device Class : 3

Duns Number: 080028759

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

ActaStim-S - 00850372007240 Catalog Number : 1101-0000

Device Description : ActaStim-S Spine Fusion Stimulator System

Device Class : 3

Duns Number: 080028759

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

ActaStim-S - 00850372007257 Catalog Number :

Device Description : ActaStim-S Spine Fusion Stimulator - Shower Covers, Electrode

Device Class : 3

Duns Number: 080028759

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

ActaStim-S - 00850372007264 Catalog Number : 1101-0001-R

Device Description : ActaStim-S Spine Fusion Stimulator Replacement Generator

Device Class : 3

Duns Number: 080028759

Premarket Exempt : No

Product Code : LOF

Prescription Use : Yes

Device Count : 1

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