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

Scissors, General, Surgical (LRW) (9) Guide, Needle, Surgical (GDF) (1)

Premarket Exempt

No Yes

Clear

Scissor - 10840199539328 Catalog Number : 9150-60

Device Description : Dietrich Coronary Artery Scissors 60 Degree Angle 18cm 7"

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

Scissor - 10840199539335 Catalog Number : 9150-90

Device Description : Dietrich Coronary Artery Scissors 90 Degree Angle 18cm 7"

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

Scissor - 10840199539342 Catalog Number : 9160-07

Device Description : Circumflex Artery Scissor 130 Degree Straight Shanks 18cm 7"

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

Scissor - 10840199539359 Catalog Number : 9165-07

Device Description : Circumflex Artery Scissor 130 Degree Curved Shanks 18cm 7"

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

Scissor - 10840199539366 Catalog Number : 9170-07

Device Description : Supersharp Cardiovascular Scissors Curved 18cm 7"

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

Scissor - 10840199539373 Catalog Number : 9170-09

Device Description : Supersharp Cardiovascular Scissors Curved 23cm 9"

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

Scissor - 10840199539380 Catalog Number : 9170-10

Device Description : Supersharp Valve Re-Do Scissors Curved 25.5cm 10"

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

Scissor - 10840199539397 Catalog Number : 9180-40

Device Description : Minimally Invasive Diethrich Type Artery Scissor 40 Degree Angle 22cm 8-3/4"

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

Scissor - 10840199539403 Catalog Number : 9190-07

Device Description : Custom Sternum Type Artery Scissor Curved 18.5cm 7-1/4"

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : LRW

Prescription Use : Yes

Device Count : 1

Needle Holder - 10840199540508 Catalog Number : 9660-07

Device Description : Sternal Wire Twister Needle Holder 17.5cm 6-3/4"

Device Class : 1

Duns Number: 007928633

Premarket Exempt : Yes

Product Code : GDF

Prescription Use : Yes

Device Count : 1

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