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

Bit, Drill (HTW) (7) Pin, Fixation, Smooth (HTY) (3)

Premarket Exempt

No Yes

Clear

Simpex Steinmann Pin - B068D187121 Catalog Number : D-187-12

Device Description : Smooth Steinmann Pin, Double Diamond Tip; 3/16" DIA x 12" LG; Material: 316L Sta Smooth Steinmann Pin, Double Diamond Tip; 3/16" 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 - B068D18712S1 Catalog Number : D-187-12S

Device Description : Smooth Steinmann Pin, Single Diamond Tip; 3/16" DIA x 12" LG; Material: 316L Sta Smooth Steinmann Pin, Single Diamond Tip; 3/16" 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 - B068D187S1 Catalog Number : D-187-S

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

Simpex Drill Bit - B068DB06251 Catalog Number : DB-062-5

Device Description : Twist Drill Bit .062" DIA x 5" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Drill Bit - B068DB07051 Catalog Number : DB-070-5

Device Description : Twist Drill Bit .070" DIA x 5" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Drill Bit - B068DB07851 Catalog Number : DB-078-5

Device Description : Twist Drill Bit .078" DIA x 5" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Drill Bit - B068DB09351 Catalog Number : DB-093-5

Device Description : Twist Drill Bit .093" DIA x 5" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Drill Bit - B068DB09851 Catalog Number : DB-098-5

Device Description : Twist Drill Bit .098" DIA x 5" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Drill Bit - B068DB109121 Catalog Number : DB-109-12

Device Description : Twist Drill Bit .109" DIA x 12" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Drill Bit - B068DB10951 Catalog Number : DB-109-5

Device Description : Twist Drill Bit .109" DIA x 5" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

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