Stanley Medical Designs, Incorporated

Address:7900 Harbor Island Drive,North Bay Village,FL,33141,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

Cutter, Surgical (FZT) (10)

Premarket Exempt

Yes

Clear

Moby® - 00850013858002 Catalog Number : 1510-01

Device Description : Green Moby® Jointed Cutter Assembly

Device Class : 1

Duns Number: 087844537

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

SoBe® - 00850013858019 Catalog Number : 1510-02

Device Description : Red SoBe® Jointed Cutter Assembly

Device Class : 1

Duns Number: 087844537

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

SoBe® - 00850013858026 Catalog Number : 1510-03

Device Description : Blue SoBe® Jointed Cutter Assembly

Device Class : 1

Duns Number: 087844537

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

Fast Fish® - 00850013858033 Catalog Number : SP-WT-001

Device Description : Fast Fish® Gauge

Device Class : 1

Duns Number: 087844537

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

Flick-Catcher® - 00850013858040 Catalog Number : SP-LSB-001

Device Description : Flick-Catcher® Left Basket, Short

Device Class : 1

Duns Number: 087844537

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

Flick-Catcher® - 00850013858057 Catalog Number : SP-RSB-001

Device Description : Flick-Catcher® Right Basket, Short

Device Class : 1

Duns Number: 087844537

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

Flick-Catcher® - 00850013858064 Catalog Number : SP-LTB-001

Device Description : Flick-Catcher® Left Basket, Tall

Device Class : 1

Duns Number: 087844537

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

Flick-Catcher® - 00850013858071 Catalog Number : SP-RTB-001

Device Description : Flick-Catcher® Right Basket, Tall

Device Class : 1

Duns Number: 087844537

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

Moby® - 00850013858088 Catalog Number : 1510-01S

Device Description : Green Moby® Jointed Cutter Package (Contains 1 each of 00850013858001, 008500138 Green Moby® Jointed Cutter Package (Contains 1 each of 00850013858001, 00850013858033, 00850013858118)

Device Class : 1

Duns Number: 087844537

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

SoBe® - 00850013858095 Catalog Number : 1510-02S

Device Description : Red SoBe® Jointed Cutter Package (Contains 1 each of 00850013858019, 00850013858 Red SoBe® Jointed Cutter Package (Contains 1 each of 00850013858019, 00850013858033, 00850013858118)

Device Class : 1

Duns Number: 087844537

Premarket Exempt : Yes

Product Code : FZT

Prescription Use : Yes

Device Count : 1

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