Provision

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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) Blade, Saw, General & Plastic Surgery, Surgical (GFA) (2)

Premarket Exempt

No Yes

Clear

Stryker - 00810041060105 Catalog Number :

Device Class : 1

Duns Number: 016889401

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

Stryker - 00810041060112 Catalog Number :

Device Class : 1

Duns Number: 016889401

Premarket Exempt : Yes

Product Code : GFA

Prescription Use : Yes

Device Count : 1

Synthes - 00810041060129 Catalog Number :

Device Class : 1

Duns Number: 016889401

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Synthes - 00810041060136 Catalog Number :

Device Class : 1

Duns Number: 016889401

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Synthes - 00810041060143 Catalog Number :

Device Class : 1

Duns Number: 016889401

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Synthes - 00810041060150 Catalog Number :

Device Class : 1

Duns Number: 016889401

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Synthes - 00810041060167 Catalog Number :

Device Class : 1

Duns Number: 016889401

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Synthes - 00810041060174 Catalog Number :

Device Class : 1

Duns Number: 016889401

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Synthes - 00810041060181 Catalog Number :

Device Class : 1

Duns Number: 016889401

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

Synthes - 00810041060198 Catalog Number :

Device Class : 1

Duns Number: 016889401

Premarket Exempt : Yes

Product Code : HTW

Prescription Use : Yes

Device Count : 1

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