KOROS U.S.A., INC.

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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 (GXZ) (8) Appliance, Fixation, Spinal Interlaminal (KWP) (2)

Premarket Exempt

No Yes

Clear

Dilator Tube Set, Single Use, Sterile - 10840199500007 Catalog Number : 7332-99D

Device Description : The dilators in the Dilator Tube Set can be used for both dilation and neuromoni The dilators in the Dilator Tube Set can be used for both dilation and neuromonitoring. It consists of the Following; 7332-73D, -74D, -75D, 76D, 86D, 89D

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

K-Wire - 10840199500014 Catalog Number :

Device Description : Disposable K- wire

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Small Dilator Tube - 10840199500021 Catalog Number :

Device Description : Disposable Small Dilator Tube 5mm

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Medium Dilator Tube - 10840199500038 Catalog Number :

Device Description : Disposable Medium Dilator Tube 9mm

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Large Dilator Tube - 10840199500045 Catalog Number :

Device Description : Disposable Large Dilator Tube 16mm

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Neuromonitoring Wire with Clip - 10840199500052 Catalog Number : 7329-120

Device Description : Neuromonitoring Wire with Clip

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Nerve Stimulator Probe - 10840199500069 Catalog Number :

Device Description : Disposable Nerve Stimulator Probe 160mm

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Disposable XL Dilator Tube - 10840199500076 Catalog Number :

Device Description : Disposable XL Dilator Tube, 23mm

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GXZ

Prescription Use : Yes

Device Count : 1

Spondylophyte Impaction Set - 10840199500113 Catalog Number : 7220-40

Device Description : Spondylophyte Impaction Set

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

Bayonet Suction Retractor - 10840199500120 Catalog Number :

Device Description : Bayonet Suction Retractor 10mm tip

Device Class :

Duns Number: 007928633

Premarket Exempt : No

Product Code : KWP

Prescription Use : Yes

Device Count : 1

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