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 (GAD) (9) Tray, Surgical, Instrument (FSM) (1)

Premarket Exempt

No Yes

Clear

CardioBay Suture Boots - 10840199538925 Catalog Number : 8980-80

Device Description : CardioBay Suture Boots Side Clip On

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

CardioBay Suture Boots - 10840199538932 Catalog Number : 8980-82

Device Description : CardioBay Suture Boots Lock Type

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Instrument Case - 10840199538949 Catalog Number : 8980-90

Device Description : CardioBay Instrument Case

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

Gerbode Style Sternum Spreader - 10840199538956 Catalog Number : 8990-00

Device Description : Gerbode Style Sternum Spreader 2.8cm x 11.5cm Blade 9" Arm 9" Opening

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Stabilizer Tower - 10840199538963 Catalog Number : 8990-60

Device Description : Stabilizer Tower

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Detachable Retractor Frame - 10840199538970 Catalog Number : 8995-10

Device Description : Detachable Retractor Frame

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Cross Bar - 10840199538987 Catalog Number : 8995-20

Device Description : Cross Bar w/ Clamp

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Table Post - 10840199538994 Catalog Number : 8995-30

Device Description : Table Post w/ Cross Clamp

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Blades - 10840199539007 Catalog Number : 8995-40

Device Description : Small Blades 1.5 x 2" Wide

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

Blades - 10840199539014 Catalog Number : 8995-50

Device Description : Medium Blades 2.5 x 1.5" wWde

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : GAD

Prescription Use : Yes

Device Count : 1

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