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

Retractor, Self-Retaining, For Neurosurgery (GZT) (10)

Premarket Exempt

No Yes

Clear

Titanium Super Slide II Self Retaining Retractor, Basic Set - 10840199500670 Catalog Number : 7329-06

Device Description : Titanium Super-Slide II Basic Retractor set consists of the following: 1x 7329-1

Device Class :

Duns Number: 007928633

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

Titanium Blade Super Slide II Self Retaining Retractor, Extended Set - 10840199500687 Catalog Number : 7329-09

Device Description : Titanium Blade Super-Slide II Basic Retractor Set Extended Consists of the Follo

Device Class :

Duns Number: 007928633

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

1” Wide Blade Stainless Steel Super-Slide Retractor Set - 10840199500700 Catalog Number : 7329-100

Device Description : Super Slide Stainless Steel 1" Wide Blade Retractor Set, Consists of the Followi

Device Class :

Duns Number: 007928633

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

Super Slide III Ti Retractor Frame - 10840199500717 Catalog Number : 7329-10M

Device Description : Super Slide III Titanium Retractor Frame Only

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

Super-Slide II Retractor Frame Stainless - 10840199500724 Catalog Number : 7329-10T

Device Description : Super-Slide II Retractor Frame Stainless

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

S-Slide Wide Blade Retractor Frame - 10840199500731 Catalog Number : 7329-110

Device Description : Super Slide Wide Blade Retractor Frame Stainless

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

Super-Slide 1" Wide Blade - 10840199500748 Catalog Number : 7329-120

Device Description : Super-Slide 1" Wide Blade 1 x 2"

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

Super-Slide 1" Wide Blade - 10840199500755 Catalog Number : 7329-125

Device Description : Super-Slide 1" Wide Blade 1 x 2 1/2"

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

Super-Slide 1" Wide Blade - 10840199500762 Catalog Number : 7329-130

Device Description : Super-Slide 1" Wide Blade 1" x 3"

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

Super-Slide 1" Wide Blade - 10840199500779 Catalog Number : 7329-135

Device Description : Super-Slide 1" Wide Blade 1 x 3 1/2"

Device Class : 2

Duns Number: 007928633

Premarket Exempt : No

Product Code : GZT

Prescription Use : Yes

Device Count : 1

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