STERILMED, INC.

Address:5010 Cheshire Pkwy N Ste 2,Plymouth,MN,55446,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

BUR, SURGICAL, GENERAL & PLASTIC SURGERY (GFF) (8) ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (2)

Premarket Exempt

No Yes

Clear

NA - 10888551000598 Catalog Number : E8130LSO

Device Description : BUR CARBIDE LSO ROUND 8 FLUTES

Device Class : 1

Duns Number: 175899459

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

NA - 10888551000604 Catalog Number : E8140LSO

Device Description : BUR CARBIDE LSO ROUND 8 FLUTES

Device Class : 1

Duns Number: 175899459

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

NA - 10888551000611 Catalog Number : E8150LSO

Device Description : BUR CARBIDE LSO ROUND 10 FLUTES

Device Class : 1

Duns Number: 175899459

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

NA - 10888551000628 Catalog Number : E8215

Device Description : BURR STAINLESS STEEL ROUND 6 FLUTES

Device Class : 1

Duns Number: 175899459

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

NA - 10888551000635 Catalog Number : E8220

Device Description : BURR STAINLESS STEEL ROUND 6 FLUTES

Device Class : 1

Duns Number: 175899459

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

NA - 10888551000642 Catalog Number : E8230LSO

Device Description : BUR CARBIDE LSO ROUND 8 FLUTES

Device Class : 1

Duns Number: 175899459

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

NA - 10888551000659 Catalog Number : E8240LSO

Device Description : BUR CARBIDE LSO ROUND 8 FLUTES

Device Class : 1

Duns Number: 175899459

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

NA - 10888551000666 Catalog Number : E8250LSO

Device Description : BUR CARBIDE FLUTED ROUND LSO

Device Class : 1

Duns Number: 175899459

Premarket Exempt : Yes

Product Code : GFF

Prescription Use : Yes

Device Count : 1

NA - 10888551000673 Catalog Number : LINESA-5296

Device Description : ELECTRODE ULTRABLATOR 90 DEGREE ANGLED

Device Class : 2

Duns Number: 175899459

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

NA - 10888551000680 Catalog Number : LINESA-5333

Device Description : ELECTRODE ULTRABLATOR 3 RIB 30 DEGREE ANGLED

Device Class : 2

Duns Number: 175899459

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

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