BIOMET

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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

MIXER, CEMENT, FOR CLINICAL USE (JDZ) (8) DISPENSER, CEMENT (KIH) (2)

Premarket Exempt

No Yes

Clear

Right-Angle Nozzle - 00880304370326 Catalog Number : 414900

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : Yes

Device Count : 1

Optivac Total Hip Kit - 00880304370562 Catalog Number : 417000

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : Yes

Device Count : 1

Optivac Kit, 40 gram single Mix - 00880304370579 Catalog Number : 417100

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : Yes

Device Count : 1

Optivac Kit, 80 gram Double Mix - 00880304370609 Catalog Number : 417200

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : Yes

Device Count : 1

Optivac Kit, 120 gram Triple Mix - 00880304370623 Catalog Number : 417300

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : Yes

Device Count : 1

Optivac Total Hip Kit - 00880304370647 Catalog Number : 418000

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : Yes

Device Count : 1

Optivac Kit, 80 gram Double Mix - 00880304370999 Catalog Number : 418200

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : Yes

Device Count : 1

Optivac Kit, 120 gram Triple Mix - 00880304371002 Catalog Number : 418300

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : Yes

Device Count : 1

Optigun II - 00880304371019 Catalog Number : 419300

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : KIH

Prescription Use : Yes

Device Count : 1

OPTIVAC FUSION - 00880304488380 Catalog Number : 419000

Device Class : 1

Duns Number: 260930126

Premarket Exempt : Yes

Product Code : JDZ

Prescription Use : Yes

Device Count : 1

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