SIG MEDICAL CORP.

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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

Plate, Fixation, Bone (HRS) (10)

Premarket Exempt

Clear

AdvantageRib - 00854865007311 Catalog Number : 04.517.020

Device Description : AdvantageRIB Fracture Kit, 75mm

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007328 Catalog Number : 323.0010

Device Description : AdvantageRib 4.0mm Drill, Brad Point

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007335 Catalog Number : 323.0071

Device Description : Small Cannulated AO Quick-Connect Handle

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007342 Catalog Number : 323.1205

Device Description : AdvantageRib Locking Cap, X-Drive

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007359 Catalog Number : 323.1206

Device Description : AdvantageRib Locking Cap, Medium, X-Drive

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007366 Catalog Number : 323.1207

Device Description : AdvantageRib Locking Cap, Large, X-Drive

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007373 Catalog Number : 323.1203

Device Description : AdvantageRib Locking Post, 23mm

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007380 Catalog Number : 323.1202

Device Description : AdvantageRib Locking Post, 18mm

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007397 Catalog Number : 323.1201

Device Description : AdvantageRib Locking Post, 10mm

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

AdvantageRib - 00854865007403 Catalog Number : 323.0075

Device Description : AdvantageRib X-Driver, AO Quick-Connect

Device Class : 2

Duns Number: 080503619

Premarket Exempt : No

Product Code : HRS

Prescription Use : Yes

Device Count : 1

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