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 - B068D140S1 Catalog Number : D-140-S

Device Description : Smooth Steinmann Pin, Single Diamond Tip; 9/64" DIA x 9" LG; Material: 316L Stai Smooth Steinmann Pin, Single Diamond Tip; 9/64" 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 Steinmann Pin - B068D1561 Catalog Number : D-156

Device Description : Smooth Steinmann Pin, Double Diamond Tip; 5/32" DIA x 9" LG; Material: 316L Stai Smooth Steinmann Pin, Double Diamond Tip; 5/32" 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 Steinmann Pin - B068D156121 Catalog Number : D-156-12

Device Description : Smooth Steinmann Pin, Double Diamond Tip; 5/32" DIA x 12" LG; Material: 316L Sta Smooth Steinmann Pin, Double Diamond Tip; 5/32" 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 - B068D15612S1 Catalog Number : D-156-12S

Device Description : Smooth Steinmann Pin, Single Diamond Tip; 5/32" DIA x 12" LG; Material: 316L Sta Smooth Steinmann Pin, Single Diamond Tip; 5/32" 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 - B068D156S1 Catalog Number : D-156-S

Device Description : Smooth Steinmann Pin, Single Diamond Tip; 5/32" DIA x 9" LG; Material: 316L Stai Smooth Steinmann Pin, Single Diamond Tip; 5/32" 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 Steinmann Pin - B068D1771 Catalog Number : D-177

Device Description : Smooth Steinmann Pin, Double Diamond Tip; .177" DIA x 9" LG; Material: 316L Stai Smooth Steinmann Pin, Double Diamond Tip; .177" 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 Steinmann Pin - B068D177121 Catalog Number : D-177-12

Device Description : Smooth Steinmann Pin, Double Diamond Tip; .177" DIA x 12" LG; Material: 316L Sta Smooth Steinmann Pin, Double Diamond Tip; .177" 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 - B068D17712S1 Catalog Number : D-177-12S

Device Description : Smooth Steinmann Pin, Single Diamond Tip; .177" DIA x 12" LG; Material: 316L Sta Smooth Steinmann Pin, Single Diamond Tip; .177" 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 - B068D177S1 Catalog Number : D-177-S

Device Description : Smooth Steinmann Pin, Single Diamond Tip; .177" DIA x 9" LG; Material: 316L Stai Smooth Steinmann Pin, Single Diamond Tip; .177" 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 Steinmann Pin - B068D1871 Catalog Number : D-187

Device Description : Smooth Steinmann Pin, Double Diamond Tip; 3/16" DIA x 9" LG; Material: 316L Stai Smooth Steinmann Pin, Double Diamond Tip; 3/16" 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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