SIMPEX MEDICAL, INC.

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

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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) (10)

Premarket Exempt

No Yes

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Simpex Steinmann Pin - B068B125121 Catalog Number : B-125-12

Device Description : Smooth Steinmann Pin, Double Blunt Tip; 1/8" DIA x 12" LG; Material: 316L Stainless Steel

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Simpex Steinmann Pin - B068D0781 Catalog Number : D-078

Device Description : Smooth Steinmann Pin, Double Diamond Tip; 5/64" DIA x 9" LG; Material: 316L Stai

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Simpex Steinmann Pin - B068D078121 Catalog Number : D-078-12

Device Description : Smooth Steinmann Pin, Double Diamond Tip; 5/64" DIA x 12" LG; Material: 316L Sta

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Simpex Steinmann Pin - B068D07812S1 Catalog Number : D-078-12S

Device Description : Smooth Steinmann Pin, Single Diamond Tip; 5/64" DIA x 12" LG; Material: 316L Sta

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Simpex Steinmann Pin - B068D078S1 Catalog Number : D-078-S

Device Description : Smooth Steinmann Pin, Single Diamond Tip; 5/64" DIA x 9" LG; Material: 316L Stai

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Simpex Steinmann Pin - B068D0931 Catalog Number : D-093

Device Description : Smooth Steinmann Pin, Double Diamond Tip; 3/32" DIA x 9" LG; Material: 316L Stai

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Simpex Steinmann Pin - B068D093121 Catalog Number : D-093-12

Device Description : Smooth Steinmann Pin, Double Diamond Tip; 3/32" DIA x 12" LG; Material: 316L Sta

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Simpex Steinmann Pin - B068D09312S1 Catalog Number : D-093-12S

Device Description : Smooth Steinmann Pin, Single Diamond Tip; 3/32" DIA x 12" LG; Material: 316L Sta

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Simpex Steinmann Pin - B068D093S1 Catalog Number : D-093-S

Device Description : Smooth Steinmann Pin, Single Diamond Tip; 3/32" DIA x 9" LG; Material: 316L Stai

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

Simpex Steinmann Pin - B068D1091 Catalog Number : D-109

Device Description : Smooth Steinmann Pin, Double Diamond Tip; 7/64" DIA x 9" LG; Material: 316L Stai

Device Class : 2

Duns Number: 932637023

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

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