SIMPEX MEDICAL, INC.

Address:1974 Carolina Place Drive,Fort Mill,SC,29708,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

Pin, Fixation, Smooth (HTY) (3)

Premarket Exempt

No Yes

Clear

Simpex Kirschner Wire - B068TK0626S1 Catalog Number : TK-062-6S

Device Description : Smooth K-Wire, Single Trocar Tip; .062" DIA x 6" LG; Material: 316L Stainless Steel

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Simpex Kirschner Wire - B068TK06291 Catalog Number : TK-062-9

Device Description : Smooth K-Wire, Double Trocar Tip; .062" DIA x 9" LG; Material: 316L Stainless Steel

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Simpex Kirschner Wire - B068TK0629S1 Catalog Number : TK-062-9S

Device Description : Smooth K-Wire, Single Trocar Tip; .062" DIA x 9" LG; Material: 316L Stainless Steel

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

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