SURETEK MEDICAL

Address:25-B MAPLE CREEK CIRCLE,GREENVILLE,SC,29607,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

Burr, Orthopedic (HTT) (6) Bit, Drill (HTW) (3) Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed (NUJ) (1)

Premarket Exempt

No Yes

Clear

Reprocessed Turbinate Handpiece - B39011204110051 Catalog Number :

Device Class : 2

Duns Number: 785616934

Premarket Exempt : No

Product Code : NUJ

Prescription Use : Yes

Device Count : 1

Reprocessed 5.5mm Cannulated Drill Bit, 210mm L - B390119174ND1 Catalog Number :

Device Class : 1

Duns Number: 785616934

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Reprocessed 4.0mm Micro Egg Bur, 10 Flute - B39014S09031 Catalog Number :

Device Class : 1

Duns Number: 785616934

Premarket Exempt : Yes

Product Code : HTT

Prescription Use : Yes

Device Count : 1

Reprocessed 2.3mm Round Diamond Bur - B390160513231 Catalog Number :

Device Class : 1

Duns Number: 785616934

Premarket Exempt : Yes

Product Code : HTT

Prescription Use : Yes

Device Count : 1

Reprocessed 6.0mm Egg Bur, 14 Flute - B3901607231 Catalog Number :

Device Class : 1

Duns Number: 785616934

Premarket Exempt : Yes

Product Code : HTT

Prescription Use : Yes

Device Count : 1

Reprocessed 4.0mm Egg Bur, 10 Flute - B39016072351 Catalog Number :

Device Description : 4.0 x 44.5mm, 10 Flute

Device Class : 1

Duns Number: 785616934

Premarket Exempt : Yes

Product Code : HTT

Prescription Use : Yes

Device Count : 1

Reprocessed 4.0mm Micro Egg Bur, 10 Flute - B39016082351 Catalog Number :

Device Description : 4.0 x 54mm, 10 Flute

Device Class : 1

Duns Number: 785616934

Premarket Exempt : Yes

Product Code : HTT

Prescription Use : Yes

Device Count : 1

Reprocessed 4.0mm Round Bur, 12 Flute - B39016082551 Catalog Number :

Device Class : 1

Duns Number: 785616934

Premarket Exempt : Yes

Product Code : HTT

Prescription Use : Yes

Device Count : 1

Reprocessed 1.5mm Wire Pass Drill Bit, 66mm - B39016082591 Catalog Number :

Device Class : 1

Duns Number: 785616934

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Reprocessed 2.0mm Wire Pass Drill Bit, 66mm - B39016082611 Catalog Number :

Device Class : 1

Duns Number: 785616934

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

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