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) (8) Pin, Fixation, Smooth (HTY) (2)

Premarket Exempt

No Yes

Clear

Simpex Drill Bit - B068DB177101 Catalog Number : DB-177-10

Device Description : Twist Drill Bit .177" DIA x 10" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Drill Bit - B068DB17751 Catalog Number : DB-177-5

Device Description : Twist Drill Bit .177" 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 - B068DB187101 Catalog Number : DB-187-10

Device Description : Twist Drill Bit .187" DIA x 10" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Drill Bit - B068DB18751 Catalog Number : DB-187-5

Device Description : Twist Drill Bit .187" 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 - B068DB235101 Catalog Number : DB-236-10

Device Description : Twist Drill Bit .236" DIA x 10" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Drill Bit - B068DB23651 Catalog Number : DB-236-5

Device Description : Twist Drill Bit .236" DIA x 10" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Drill Bit - B068DB250101 Catalog Number : DB-250-10

Device Description : Twist Drill Bit .250" DIA x 10" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Drill Bit - B068DB25051 Catalog Number : DB-250-5

Device Description : Twist Drill Bit .250" DIA x 5" LG

Device Class : 1

Duns Number: 932637023

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Simpex Kirschner Wire - B068KD028121 Catalog Number : KD-028-12

Device Description : Smooth K-Wire, Double Diamond Tip; .028" 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 Kirschner Wire - B068KD02812S1 Catalog Number : KD-028-12S

Device Description : Smooth K-Wire, Single Diamond Tip; .028" 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

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